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Tramadol Hydrochloride 50 mg Tablet, Coated, 40-count — NDC 72189-0311-40 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tramadol Hydrochloride 50 mg Tablet, Coated, 40-count — NDC 72189-311-40 (Billing 72189-0311-40)

by DirectRx · 40 TABLET, COATED in 1 BOTTLE

This is a package of 40 tablets of Tramadol Hydrochloride 50 mg Tablet, Coated from DirectRx, marketed since Jan 2022 and currently FDA-listed.

NDC 72189-0311-40
🏷️ FDA NDC (as labeled) 72189-311-40 billing pads the product segment with a zero
This package
Contains40-count Pack sizes9 compare ↓
Also priced by: Part D plans $0.1012/unit — full pricing hub ↓
Product page 72189-0311-12 Also comes in: 12 tablets 72189-311-12 20 tablets 72189-311-20 30 tablets 72189-311-30 60 tablets 72189-311-60 90 tablets 72189-311-90 120 tablets 72189-311-72 180 tablets 72189-311-82 240 tablets 72189-311-84
Rx only Generic On market CIV 🛡 REMS ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 72189-311-40 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72189 labeler · 311 product · 40 package
Package marketed since
Jan 12, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
40 EA per package
Barcode (UPC-A, from the NDC)
3 7218931140 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Tramadol Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 26, 2024 — Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol (Rubicon Research Private Limited) · FDA recall D-0487-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-311-40
Product NDC 72189-311
11-digit billing NDC 72189031140
NCPDP billing unit EA — each (per item)
RxCUI 835603
UNII 9N7R477WCK
Application # ANDA208708
SPL Set ID d5685c80-c84d-d0a1-e053-2995a90afc54
Established class (EPC) Opioid Agonist
Mechanism of action Full Opioid Agonists
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-12
Route ORAL
Dosage form TABLET, COATED
Substance TRAMADOL HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 65100095100320
GPI class traMADol HCl
GCN Seq No 023139
GCN 07221
HICL code 008317
Ingredient (HICL) Tramadol Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3A
Therapeutic class — specific (HIC3) Opioid Analgesics
AHFS code 28:08.08.00
AHFS class Opioid Agonists (28:08)
FDB label name TRAMADOL HCL 50 MG TABLET
FDB brand name Tramadol Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 023139
  • GCN: 07221
  • GPI-14 (Medi-Span): 65100095100320
  • HICL (First Databank): 008317
  • AHFS class code: 28:08.08.00
  • RxCUI (RxNorm): 835603
Why two NDCs? The FDA registers this code as 72189-311-40 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72189-0311-40. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Other opioids
How it works Full Opioid Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TRAMADOL HCL 50 MG TABLET Ingredient Tramadol Hcl
📖 What it is MedlinePlus · NLM

Tramadol is used to relieve certain types of pain. Tramadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats pain that is severe enough to need an opioid when other options haven’t worked or can’t be tolerated. Extended-release forms are for ongoing, around-the-clock pain, not a...
  • Take it by mouth exactly as prescribed. If you have extended-release tablets, swallow them whole, never crush, chew or cut them. Don’t take it with other tramadol products.
  • Dizziness, nausea, constipation, headache, sleepiness, itching and dry mouth are common. Call your doctor for seizures, severe dizziness, or agitation, fever and shaking. Slow brea...
  • Avoid alcohol. Mixing tramadol with alcohol, sleep aids, benzodiazepines or other opioids can cause dangerous sedation and slowed breathing. Tell me about any antidepressants, MAOI...
📖 Read our full Tramadol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1012 $4.05 / 40 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72189-0311-12 72189-311-12 Main listing 12 TABLET, COATED in 1 BOTTLE 2022-01-12 — Active
72189-0311-20 72189-311-20 20 TABLET, COATED in 1 BOTTLE 2022-01-12 — Active
72189-0311-30 72189-311-30 30 TABLET, COATED in 1 BOTTLE 2022-01-12 — Active
72189-0311-40 You're viewing this 40 TABLET, COATED in 1 BOTTLE 2022-01-12 — Active
72189-0311-60 72189-311-60 60 TABLET, COATED in 1 BOTTLE 2022-01-12 — Active
72189-0311-72 72189-311-72 120 TABLET, COATED in 1 BOTTLE 2022-01-12 — Active
72189-0311-82 72189-311-82 180 TABLET, COATED in 1 BOTTLE 2022-01-12 — Active
72189-0311-90 72189-311-90 90 TABLET, COATED in 1 BOTTLE 2022-01-12 — Active
72189-0311-84 72189-311-84 240 TABLET, COATED in 1 BOTTLE 2022-01-12 — Active

You're viewing one of 9 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 40-count package — 40 tablet, coated in 1 bottle.
How does this package differ from NDC 72189-0311-12?
Both are Tramadol Hydrochloride 50 mg Tablet, Coated — the drug itself is identical. This page's package is the 40-count one, while NDC 72189-0311-12 is the 12 tablets package.
What NDC number is used to bill for this package of Tramadol Hydrochloride 50 mg Tablet, Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tramadol Hydrochloride 50 mg 00093-3301-01 Teva 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 00904-7496-61 Major 1 tablet $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 16571-0716-01 Rising 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 29300-0355-01 Unichem 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 60219-2348-01 Amneal 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 60687-0795-01 American 1 tablet $0.025 AB Availability likely —
tramadol hydrochloride 50 mg 64380-0791-01 Strides 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 64980-0614-01 Rising 100 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 72888-0080-00 Advagen 1000 tablets $0.025 AB Availability likely —
Tramadol Hydrochloride 50 mg 52817-0195-00 TRUPHARMA 1000 tablets $0.033 AB FDA listed —
Tramadol Hydrochloride 50 mg 27808-0301-01 Cranbury 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 50090-5789-00 A-S 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 50090-5790-01 A-S 90 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 51407-0007-01 Golden 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 55700-0997-01 Quality 120 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 58118-2348-08 Clinical 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 59651-0441-01 Aurobindo 100 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 60760-0588-30 ST. 30 tablets — AB Discontinued —
Tramadol Hydrochloride 50 mg 60760-0727-09 St. 9 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 60760-0772-09 ST. 9 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 63187-0063-15 Proficient 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 65162-0627-01 Amneal 10 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 67046-1209-03 Coupler 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 67296-1834-01 RedPharm 10 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 68071-3644-03 NuCare 30 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 68071-3655-02 NuCare 12 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68071-4119-01 NuCare 120 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68788-4035-01 Preferred 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68788-4040-01 Preferred 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68788-4114-01 Preferred 90 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 68788-8121-01 Preferred 100 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 68788-8717-01 Preferred 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 69238-2348-01 Amneal 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 70518-3824-00 REMEDYREPACK 30 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 70518-4248-00 REMEDYREPACK 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71205-0740-15 Proficient 15 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 71335-2518-00 Bryant 50 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 71335-2612-01 Bryant 8 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71335-2721-01 Bryant 8 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71335-3147-00 Bryant 50 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71335-9658-00 Bryant 50 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71610-0006-15 Aphena 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 71610-0865-15 Aphena 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mgthis 72189-0311-40 DirectRx 40 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 76420-0733-00 Asclemed 1000 tablets — AB FDA listed —
Tramadol HCL 50 mg 80425-0057-01 Advanced 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0274-01 Advanced 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0276-01 Advanced 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0501-01 Advanced 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0548-01 Advanced 15 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 82804-0114-15 Proficient 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 82804-0142-15 Proficient 15 tablets — AB FDA listed —
tramadol hydrochloride 50 mg 82868-0052-30 Northwind 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 87063-0117-01 Asclemed 100 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 80425-0588-01 Advanced 15 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 82868-0110-30 Northwind 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 70518-4713-00 REMEDYREPACK 30 tablets — AB FDA listed —
Tramadol Hydrochloride 50 mg 87441-0089-01 Unit 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeCapsule
Imprint018
Size13 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDirectRx
Application holderRUBICON RESEARCH LTD
FDA applicationANDA208708 (ANDA)
Labeler code72189
First marketedJan 2022
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio49 products on file

More NDCs from DirectRx labeler code 72189

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 91 words ▾

Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated or are not expected to be tolerated.

Have not provided adequate analgesia or are not expected to provide adequate analgesia.

⏱️ Dosage and Administration ~3 min read ▾

2.1Important Dosage and Administration Instructions Do not use Tramadol hydrochloride tablets concomitantly with other tramadol-containing products. Do not administer Tramadol hydrochloride tablets at a dose exceeding 400 mg per day. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see WARNINGS AND PRECAUTIONS (5.1) ].

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [ see WARNINGS AND PRECAUTIONS (5.1) ]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with tramadol hydrochloride tablets and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS (5.3)].

2.2Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with tramadol hydrochloride tablets [see WARNINGS AND PRECAUTIONS (5.3), PATIENT COUNSELING INFORMATION (17)] . Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).

Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. However, the presence of risk factors for overdose should not prevent the proper management of pain in any given patient [see WARNINGS AND PRECAUTIONS (5.1, 5.3, 5.7)] . Consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental exposure or overdose.

2.3Initial Dosage Initiating Treatment with tramadol hydrochloride tablets For patients not requiring rapid onset of analgesic effect, the tolerability of tramadol hydrochloride tablets can be improved by initiating therapy with the following titration regimen: Start tramadol hydrochloride tablets at 25 mg/day and titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg four times a day). Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg four times a day).

After titration, tramadol hydrochloride tablets 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day. For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, tramadol hydrochloride tablets 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day. Conversion from tramadol hydrochloride to Extended-Release tramadol The relative bioavailability of tramadol hydrochloride compared to extended-release tramadol is unknown, so conversion to extended-release formulations must be accompanied by close observation for signs of excessive sedation and respiratory depression.

Dosage Modification in Patients with Hepatic Impairment The recommended dose for adult patients with severe hepatic impairment is 50 mg every 12 hours. Dosage Modification in Patients with Renal Impairment In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride tablets be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.

Do… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 52 words ▾

Tramadol Hydrochloride Tablets, USP 50 mg are white to off white, capsule-shaped film coated tablet debossed with “018” on one side and scored on other side. Tramadol Hydrochloride Tablets, USP 100 mg are white to off white, capsule-shaped film coated tablet debossed with “019” on one side and scored on other side.

⚠️ Warnings and Cautions ~3 min read ▾

5.1Addiction, Abuse, and Misuse Tramadol hydrochloride tablets contains tramadol, a Schedule IV controlled substance. As an opioid, tramadol hydrochloride tablets exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE (9)] . Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed tramadol hydrochloride tablets.

Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing tramadol hydrochloride tablets, and monitor all patients receiving tramadol hydrochloride tablets for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).

The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as tramadol hydrochloride tablets, but use in such patients necessitates intensive counseling about the risks and proper use of tramadol hydrochloride tablets along with intensive monitoring for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose [see DOSAGE AND ADMINISTRATION (2.2), WARNINGS AND PRECAUTIONS (5.3)] .

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing tramadol hydrochloride tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see PATIENT COUNSELLING INFORMATION (17)] .

Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

5.2Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS- compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following: Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain.

Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed. The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG . Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them.

Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities. To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com. FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint .

5.3Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Ma… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [ see WARNINGS AND PRECAUTIONS (5.1)] Life-Threatening Respiratory Depression [ see WARNINGS AND PRECAUTIONS (5.3)] Utra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children [ see WARNINGS AND PRECAUTIONS (5.4)] Neonatal Opioid Withdrawal Syndrome [ see WARNINGS AND PRECAUTIONS (5.5)] Interactions with Benzodiazepines or Other CNS Depressants [ see WARNINGS AND PRECAUTIONS (5.7)] Serotonin Syndrome [ see WARNINGS AND PRECAUTIONS (5.8)] Seizures [ see WARNINGS AND PRECAUTIONS (5.9)] Suicide [ see WARNINGS AND PRECAUTIONS (5.10)] Adrenal Insufficiency [ see WARNINGS AND PRECAUTIONS (5.11)] Severe Hypotension [ see WARNINGS AND PRECAUTIONS (5.13)] Gastrointestinal Adverse Reactions [ see WARNINGS AND PRECAUTIONS (5.15)] Hypersensitivity Reactions [ see WARNINGS AND PRECAUTIONS (5.16)] Withdrawal [ see WARNINGS AND PRECAUTIONS (5.17)]

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tramadol hydrochloride tablets were administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older.

Table 1 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to tramadol hydrochloride tablets administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication.

The overall incidence rates of adverse experiences in these trials were similar for tramadol hydrochloride tablets and the active control groups, TYLENOL with Codeine #3 (acetaminophen 300 mg with codeine phosphate 30 mg), and aspirin 325 mg with codeine phosphate 30 mg, however, the rates of withdrawals due to adverse events appeared to be higher in the tramadol hydrochloride tablets groups. Table 1: Cumulative Incidence of Adverse Reactions for Tramadol Hydrochloride tablets in Chronic Trials of Nonmalignant Pain (N=427) 1"CNS Stimulation" is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations Up to 7 Days Up to 30 Days Up to 90 Days Dizziness/Vertigo 26% 31% 33% Nausea 24% 34% 40% Constipation 24% 38% 46% Headache 18% 26% 32% Somnolence 18% 23% 25% Vomiting 9% 13% 17% Pruritus 8% 10% 11% "CNS Stimulation" 1 7% 11% 14% Asthenia 6% 11% 12% Sweating 6% 7% 9% Dyspepsia 5% 9% 13% Dry Mouth 5% 9% 10% Diarrhea 5% 6% 10% Incidence 1% to Less than 5% Possibly Causally Related The following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with tramadol hydrochloride tablets exists.

Body as a Whole: Malaise. Cardiovascular: Vasodilation. Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder.

Gastrointestinal: Abdominal pain, Anorexia, Flatulence. Musculoskeletal: Hypertonia. Skin: Rash.

Special Senses: Visual disturbance. Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention. Incidence Less than 1%, Possibly Causally Related The following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials of tramadol and/or reported in post-marketing experience with tramadol-containing product.

Body as a Whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal te… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

Table 2: Clinically Significant Drug Interactions with tramadol hydrochloride tablets Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride tablets and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride tablets are achieved. Since M1 is a more potent μ-opioid agonist, decreased M1 exposure could result in decreased therapeutic effects, and may result in signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol.

Increased tramadol exposure can result in increased or prolonged therapeutic effects and increased risk for serious adverse events including seizures and serotonin syndrome. After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease and the M1 plasma concentration will increase. This could increase or prolong therapeutic effects but also increase adverse reactions related to opioid toxicity, such as potentially fatal respiratory depression [ see CLINICAL PHARMACOLOGY (12.3)].

Intervention: If concomitant use of a CYP2D6 inhibitor is necessary, follow patients closely for adverse reactions including opioid withdrawal, seizures and serotonin syndrome. If a CYP2D6 inhibitor is discontinued, consider lowering tramadol hydrochloride tablets dosage until stable drug effects are achieved. Follow patients closely for adverse events including respiratory depression and sedation.

Examples Quinidine, fluoxetine, paroxetine and bupropion Inhibitors of CYP3A4 Clinical Impact: The concomitant use of tramadol hydrochloride tablets and CYP3A4 inhibitors can increase the plasma concentration of tramadol and may result in a greater amount of metabolism via CYP2D6 and greater levels of M1. Follow patients closely for increased risk of serious adverse events including seizures and serotonin syndrome, and adverse reactions related to opioid toxicity including potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride tablets are achieved.

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease [ see CLINICAL PHARMACOLOGY (12.3)], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to tramadol. Intervention: If concomitant use is necessary, consider dosage reduction of tramadol hydrochloride tablets until stable drug effects are achieved. Follow patients closely for seizures and serotonin syndrome, and signs of respiratory depression and sedation at frequent intervals.

If a CYP3A4 inhibitor is discontinued, consider increasing the tramadol hydrochloride tablets dosage until stable drug effects are achieved and follow patients for signs and symptoms of opioid withdrawal. Examples Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers Clinical Impact: The concomitant use of tramadol hydrochloride tablets and CYP3A4 inducers can decrease the plasma concentration of tramadol [ see CLINICAL PHARMACOLOGY (12.3)], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to tramadol.

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the tramadol plasma concentration will increase [ see CLINICAL PHARMACOLOGY (12.3)], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause seizures, serotonin syndrome, and/or potentially fatal respiratory depression. Intervention: If concomitant use is necessary, consider increasing the tramadol hydrochloride tablets dosage until stable drug effects are achieved. Follow patients for signs of opioid withdrawal.

If… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with tramadol hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and 3.6 times the maximum recommended human daily dosage (MRHD).

Tramadol decreased pup body weight and increased pup mortality at 1.2 and 1.9 times the MRHD [see Data]. Based on animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in respiratory depression and physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Neonatal opioid withdrawal syndrome can present as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms and signs of neonatal opioid withdrawal syndrome and manage accordingly [see WARNINGS AND PRECAUTIONS (5.5)] .

Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during post-marketing. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate.

Tramadol hydrochloride tablets are not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including tramadol hydrochloride tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor.

Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor.

The effect of tramadol hydrochloride tablets, if any, on the later growth, development, and functional maturation of the child is unknown. Data Animal Data Tramadol has been shown to be embryotoxic and fetotoxic in mice, (120 mg/kg), rats (25 mg/kg) and rabbits (75 mg/kg) at maternally toxic dosages, but was not teratogenic at these dose levels. These doses on a mg/m 2basis are 1.4, 0.6, and 3.6 times the maximum recommended human daily dosage (MRHD) for mouse, rat and rabbit, respectively.

No drug-related teratogenic effects were observed in progeny of mice (up to 140 mg/kg), rats (up to 80 mg/kg) or rabbits (up to 300 mg/kg) treated with tramadol by various routes. Embryo and fetal toxicity consisted primarily of decreased fetal weights, decreased skeletal ossification and increased supernumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage ~2 min read ▾

Clinical Presentation Acute overdosage with tramadol hydrochloride tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, QT prolongation, hypotension, partial or complete airway obstruction, atypical snoring, seizures, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations. Deaths due to overdose have been reported with abuse and misuse of tramadol [see WARNINGS AND PRECAUTIONS (5.1); DRUG ABUSE AND DEPENDENCE (9.2)] .

Review of case reports has indicated that the risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol or other CNS depressants, including other opioids. Treatment of Overdose In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.

Cardiac arrest or serious arrhythmias will require advanced life-supporting measures. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist.

While naloxone will reverse some, but not all, symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. In animals, convulsions following the administration of toxic doses of tramadol hydrochloride tablets could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice.

Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period. Because the duration of opioid reversal is expected to be less than the duration of action of tramadol in tramadol hydrochloride tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product's prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action Tramadol hydrochloride tablets contains tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re-uptake. Although the mode of action is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to μ-opioid receptors and weak inhibition of re-uptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to μ-opioid receptors.

In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in μ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound [see CLINICAL PHARMACOLOGY (12.2)] .

Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.

12.2Pharmacodynamics Effects on the Central Nervous System Tramadol produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. Tramadol administration may produce a constellation of symptoms including nausea and vomiting, dizziness, and somnolence.

Tramadol causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.

Effects on the Gastrointestinal Tract and Other Smooth Muscle Tramadol causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation.

Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase. Effects on the Cardiovascular System Tramadol produces peripheral vasodilation, which may result in orthostatic hypotension or syncope. Manifestations of peripheral vasodilation may include pruritus, flushing, red eyes, sweating and/or orthostatic hypotension.

The effect of oral tramadol on the QTcF interval was evaluated in a double-blind, randomized, four-way crossover, placebo-and positive-(moxifloxacin) controlled study in 68 adult male and female healthy subjects. At a 600 mg/day dose (1.5-fold the maximum immediate-release daily dose), the study demonstrated no significant effect on the QTcF interval. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans.

They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon [see WARNINGS AND PRECAUTIONS (5.11); ADVERSE REACTIONS (6)] . Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see ADVERSE REACTIONS (6)].

Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal mod… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 134 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Tramadol Hydrochloride Tablets, USP 50 mg are white to off white, capsule-shaped film coated tablet debossed with “018” on one side and scored on other side. Bottles of 100 tablets……. NDC 72888-080-01 Bottles of 500 tablets….....

NDC 72888-080-05 Bottles of 1,000 tablets…...NDC 72888-080-00 Tramadol Hydrochloride Tablets, USP 100 mg are white to off white, capsule-shaped film coated tablet debossed with “019” on one side and scored on other side. Bottles of 100 tablets……. NDC 72888-008-01 Bottles of 500 tablets….....

NDC 72888-008-05 Bottles of 1,000 tablets…... NDC 72888-008-00 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].

Store tramadol hydrochloride tablets securely and dispose of properly [ see PATIENT COUNSELLING INFORMATION (17)]

📋 Description 121 words ▾

Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is: [tramadol-hcl-tabs-structure] The molecular weight of tramadol hydrochloride is 299.8.

Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7.

Tramadol Hydrochloride Tablets, USP 50 mg and Tramadol Hydrochloride Tablets, USP 100 mg contain 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide.

💬 Medication Guide ~3 min read ▾

Medication Guide Tramadol Hydrochloride (TRAM-a-dol HYE-droe-KLOR-ide) Tablets, USP CIV Tramadol hydrochloride tablets are: A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about tramadol hydrochloride tablets: Get emergency help or call 911 right away if you take too much tramadol hydrochloride tablets (overdose) . When you first start taking tramadol hydrochloride tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.

Taking tramadol hydrochloride tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your tramadol hydrochloride tablets. They could die from taking it.

Selling or giving away tramadol hydrochloride tablets are against the law. Store tramadol hydrochloride tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Important Information Guiding Use in Pediatric Patients: Do not give tramadol hydrochloride tablets to a child younger than 12 years of age.

Do not give tramadol hydrochloride tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids. Avoid giving tramadol hydrochloride tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems. Do not take tramadol hydrochloride tablets if you have: Severe asthma, trouble breathing, or other lung problems.

A bowel blockage or have narrowing of the stomach or intestines. An allergy to tramadol. Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.

Before taking tramadol hydrochloride tablets, tell your healthcare provider if you have a history of: head injury, seizures problems urinating liver, kidney, thyroid problems pancreas or gallbladder problem abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems." below "problems urinating" Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of tramadol hydrochloride tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. breastfeeding .

Not recommended; it may harm your baby. living in a household where there are small children or someone who has abused street or prescription drugs. taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking tramadol hydrochloride tablets with certain other medicines can cause serious side effects that could lead to death. When taking tramadol hydrochloride tablets: Do not change your dose.

Take tramadol hydrochloride tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. Take your prescribed dose as indicated by your healthcare provider.

The maximum dosage is 1 or 2 tablets every 4 to 6 hours, as needed for pain relief. Do not take more than your prescribed dose and do not take more than 8 tablets per day. If you miss a dose, take your next dose at your usual time.

Call your healthcare provider if the dose you are taking does not control your pain. If you have been tak… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 9 words ▾

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fhtyfgh

72189-311-20

72189-311-84

72189-311-30

72189-311-40

72189-311-82

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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This drug has a REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It may require enrollment, counseling, or monitoring to manage a serious risk. See the boxed warning & full label below, and REMS@FDA ↗.

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← 72189-0310-30 · Directrx 72189-0312-03 · DirectRx →
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