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Loperamide Hydrochloride 2 mg Capsule, 500-count — NDC 51407-0999-05 package photo

Loperamide Hydrochloride 2 mg Capsule, 500-count

by Golden State Medical Supply, Inc. · 500 CAPSULE in 1 BOTTLE (51407-999-05)
NDC 51407-0999-05
🏷️ FDA NDC (as labeled) 51407-999-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.2376/unit — full pricing hub ↓
Also comes in: 100 capsules 51407-0999-01
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 51407-999-05
Product NDC 51407-999
11-digit billing NDC 51407099905
NCPDP billing unit EA — each (per item)
RxCUI 978006
UNII 77TI35393C
Application # ANDA215001
SPL Set ID 396f7e13-b357-52be-e063-6394a90a92fc
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-10-06
Route ORAL
Dosage form CAPSULE
Substance LOPERAMIDE HYDROCHLORIDE
GCN Seq No 002842
GCN 08370
HICL code 001236
Ingredient (HICL) Loperamide Hcl
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6D
Therapeutic class — specific (HIC3) Antidiarrheals
AHFS code 56:08.00.00
AHFS class Antidiarrhea Agents
FDB label name LOPERAMIDE 2 MG CAPSULE
FDB brand name Loperamide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 51407-999-05 — 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 → 51407-0999-05. 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) Antipropulsives
How it works 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.

🏭 Manufacturer & labeler

LabelerGolden State Medical Supply, Inc.
Application holderEDENBRIDGE PHARMACEUTICALS LLC
FDA applicationANDA215001 (ANDA)
Labeler code51407
First marketedOct 2021
Product typeHuman Prescription Drug
Portfolio661 products on file
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.

🩺 Clinical

Label name LOPERAMIDE 2 MG CAPSULE Ingredient Loperamide Hcl
📖 What it is MedlinePlus · NLM

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Lop...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Loperamide works by binding to the same type of receptors in your gut that opioids do, but it stays mostly in the intestines and very little gets into your bloodstream at the recom...
  • What exactly does loperamide do — and is it like taking an opioid?
  • For acute diarrhea, stop and call your doctor if symptoms don't improve within 2 days, or if they get worse. You should also stop right away if you develop bloating or a swollen be...
  • How long can I take loperamide before I should see a doctor?
📖 Read our full Loperamide 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.

💊 What it looks like

Color brown
ShapeCapsule
Imprint605
Size14 mm
ScoringNot scored
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 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 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.

13 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.

💲 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 $0.2376 $118.80 / 500 capsules
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loperamide Hydrochloride 2 mg 00093-0311-01 Teva 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 00378-2100-01 Mylan 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 00904-7472-61 Major 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 42799-0605-01 Edenbridge 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 50268-0482-15 AvPAK 50 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 51079-0690-20 Mylan 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 59651-0691-01 Aurobindo 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 60687-0229-01 American 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 69452-0271-20 Bionpharma 100 capsules $0.056 AB Availability likely —
Loperamide hydrochloride 2 mg 72578-0138-01 Viona 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 72603-0328-01 NorthStar 100 capsules $0.056 AB Availability likely —
Anti-Diarrheal 2 mg 46122-0581-62 AMERISOURCE 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 70000-0461-01 CARDINAL 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 70677-1062-01 STRATEGIC 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 83324-0208-12 CHAIN 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 83324-0209-24 CHAIN 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 63868-0876-12 CHAIN 12 capsules $0.140 — FDA listed —
Anti-Diarrheal 2 mg 62011-0390-01 Strategic 12 capsules $0.150 — FDA listed —
Anti-Diarrheal 2 mg 00363-1176-08 WALGREENS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 00615-8497-39 NCS 30 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 11673-0177-12 TARGET 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 11822-7834-02 Rite 12 capsules — — FDA listed —
anti-diarrheal 2 mg 21130-0835-12 Albertsons 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 30142-0159-08 KROGER 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 36800-0208-12 TOP 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 37808-0988-12 HEB 12 capsules — — FDA listed —
anti-diarrheal 2 mg 41250-0210-08 MEIJER 12 capsules — — FDA listed —
First Aid Direct Anti-Diarrheal 2 mg 42961-0103-02 Cintas 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 43063-0020-12 PD-Rx 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 43598-0770-24 Dr. 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 48433-0063-20 Safecor 100 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 49035-0483-12 Wal-Mart 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 50090-0460-00 A-S 15 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 50090-7398-00 A-S 15 capsules — AB FDA listed —
Imodium A-D 2 mg 50580-0367-01 Kenvue 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mgthis 51407-0999-05 Golden 500 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 53943-0176-12 DISCOUNT 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-4699-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55154-5585-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55289-0315-06 PD-Rx 6 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 55910-0176-08 DOLGENCORP, 12 capsules — — FDA listed —
anti-diarrheal 2 mg 56062-0680-12 PUBLIX 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0727-74 Aurohealth 6 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 60468-0005-01 allphamed 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 63629-8747-01 Bryant 100 capsules — AB FDA listed —
anti-diarrheal 2 mg 63941-0684-12 VALU 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 66267-0132-12 NuCare 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67046-1676-03 Coupler 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67296-2172-01 Redpharm 15 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 68016-0058-12 Premier 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 68071-2257-06 NuCare 6 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-2700-01 NuCare 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-3618-01 NuCare 12 capsules — AB FDA listed —
anti-diarrheal 2 mg 69452-0176-12 Bionpharma 24 capsules — — FDA listed —
anti-diarrheal 2 mg 69452-0266-12 Bionpharma 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 69842-0061-12 CVS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 70518-4283-00 REMEDYREPACK 30 capsules — AB FDA listed —
Loperamide hydrochloride 2 mg 70771-1769-01 Zydus 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-1921-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2061-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2111-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2487-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2571-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0648-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0781-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0950-30 Aphena 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0973-53 Aphena 60 capsules — AB FDA listed —
anti-diarrheal 2 mg 72288-0313-12 Amazon.com 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 72888-0130-00 Advagen 1000 capsules — AB FDA listed —
WELMATE Anti Diarrheal Loperamide HCl Softgels 2 mg 73581-0102-24 YYBA 24 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 75907-0097-12 Dr. 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 80136-0851-42 Northeast 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-0277-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 59556-0959-05 Strides 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 73581-0177-02 YYBA 12 capsules — — 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

🏛️
2021
On the market since
Oct 2021
📍
2026
Currently FDA-listed
5 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for LOPERAMIDE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Diarrhoea9,086
Nausea4,381
Fatigue3,945
Vomiting2,858
Constipation2,668
Weight Decreased2,118
Headache2,063

Age at onset

Neonate13
Infant24
Child103
Adolescent111
Adult5,069
Elderly7,388

Reporter sex

50,042 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization16,195
Death3,923
Life-threatening1,723
Disabling651
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,121 1,802
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51407-0999-01 100 CAPSULE in 1 BOTTLE (51407-999-01) 2025-07-07 Active
51407-0999-05 You're viewing this 500 CAPSULE in 1 BOTTLE (51407-999-05) 2025-07-07 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 51407-0999-05?
NDC 51407-0999-05 is a 500-count package — 500 capsule in 1 bottle.
What is the difference between NDC 51407-0999-05 and NDC 51407-0999-01?
Both are Loperamide Hydrochloride 2 mg Capsule — the drug itself is identical. NDC 51407-0999-05 is the 500-count package, while NDC 51407-0999-01 is the 100 capsules package.
What NDC number is used to bill for this package of Loperamide Hydrochloride 2 mg Capsule?
Bill NDC 51407-0999-05 — the 11-digit billing format is 51407099905. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51407-999-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51407-0999-05, written without dashes as 51407099905. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51407-0999-05, the first segment (51407) is the labeler code FDA assigned to Golden State Medical Supply, Inc.; the middle segment (0999) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Golden State Medical Supply, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 capsules (51407-0999-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Golden State Medical Supply, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 86 words ▾

BOXED WARNING WARNING: TORSADES DE POINTES AND SUDDEN DEATH Cases of Torsades de Pointes, cardiac arrest, and death have been reported with the use of a higher than recommended dosages of Loperamide Hydrochloride Capsules (see WARNINGS and OVERDOSAGE). Loperamide Hydrochloride Capsules is contraindicated in pediatric patients less than 2 years of age (see CONTRAINDICATIONS). Avoid Loperamide Hydrochloride Capsules dosages higher than recommended in adults and pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (see DOSAGE AND ADMINISTRATION).

🎯 Indications and Usage 53 words ▾

INDICATIONS & USAGE Loperamide Hydrochloride Capsules (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide Hydrochloride Capsules is also indicated for reducing the volume of discharge from ileostomies.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE & ADMINISTRATION Loperamide Hydrochloride Capsules is contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see CONTRAINDICATIONS ). Avoid Loperamide Hydrochloride Capsules dosages higher than recommended in adult or pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (See WARNINGS, OVERDOSAGE ). (1 capsule = 2 mg) Patients should receive appropriate fluid and electrolyte replacement as needed.

Acute Diarrhea Adults and Pediatric Patients 13 Years and Older: The recommended initial dose is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. The maximum daily dose is 16mg (eight capsules). Clinical improvement is usually observed within 48 hours.

Pediatric Patients 2 to 12 Years of Age : In pediatric patients 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation of loperamide (1 mg/5 mL) should be used; for ages 6-12, either loperamide hydrochloride capsules or the non-prescription liquid formulation of loperamide may be used. For pediatric patients 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements: Recommended First Day Dosage Schedule Two to five years (13 to 20 kg): 1 mg three times daily (3 mg total daily dosage) Six to eight years (20 to 30 kg): 2 mg twice daily.

(4 mg total daily dosage) Eight to twelve years (greater than 30kg): 2 mg three times daily (6 mg total daily dosage) Recommended Subsequent Daily Dosage Following the first treatment day, it is recommended that subsequent Loperamide Hydrochloride Capsules doses (1 mg/10 kg body weight) be administered only after a loose stool. The total daily dosage should not exceed recommended dosages for the first day. Chronic Diarrhea Adults 'The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of Loperamide Hydrochloride Capsules should be reduced to meet individual requirements.

When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses. The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules per day). The maximum daily dosage is 16 mg (eight capsules per day).

If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. Loperamide Hydrochloride Capsules administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment. Elderly No formal pharmacokinetic studies were conducted in elderly subjects.

However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dose adjustment is required for the elderly. In general, elderly patients may be more susceptible to drug-associated effects of the QT interval.

Avoid Loperamide Hydrochloride Capsules in elderly patients taking drugs that can result in prolongation of the QT interval (for example, Class IA or III antiarrhythmics) or in patients with risk factors for Torsades de Pointes (see WARNINGS ). Renal Impairment No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment (see PRECAUTIONS ).

Hepatic Impairment The pharmacokinetics of loperamide have not been studied in patients with hepatic impairment. Use Loperamide Hydrochloride Capsules with caution in such patients because the systemic exposure may be increased due to reduced metabolism (see PRECAUTIONS ).

⛔ Contraindications 103 words ▾

CONTRAINDICATIONS Loperamide Hydrochloride Capsules is contraindicated in: pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see WARNINGS ). patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. patients with abdominal pain in the absence of diarrhea. patients with acute dysentery, which is characterized by blood in stools and high fever. patients with acute ulcerative colitis. patients with bacterial enterocolitis caused by invasive organisms including Salmonella , Shigella , and Campylobacter . patients with pseudomembranous colitis (e.g., Clostridium difficle ) associated with the use of broad-spectrum antibiotics.

⚠️ Warnings ~2 min read ▾

WARNINGS Cardiac Adverse Reactions, Including Torsades de Pointes and Sudden Death Cases of prolongation of the QT/QTc interval, Torsades de Pointes, other ventricular arrhythmias, cardiac arrest, some resulting in death, have been reported in adults with use of higher than recommended doses per day of Loperamide Hydrochloride Capsules Cases include patients who were abusing or misusing loperamide hydrochloride (see OVERDOSAGE and DRUG ABUSE AND DEPENDENCE ). Cases of syncope and ventricular tachycardia have been reported in adult patients receiving the recommended dosage of Loperamide Hydrochloride Capsules.

Some of these patients were taking other drugs or had other risk factors that may have increased their risk of cardiac adverse reactions. Additionally, postmarketing cases of cardiac arrest, syncope, and respiratory depression have been reported in pediatric patients less than 2 years of age. Loperamide Hydrochloride Capsules is contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions.

Avoid Loperamide Hydrochloride Capsules dosages higher than recommended in adults and pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (see DOSAGE AND ADMINISTRATION, OVERDOSAGE ) Avoid Loperamide Hydrochloride Capsules in: combination with others drugs or herbal products that are known to prolong the QT interval, including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, antipsychotics (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), or any other drug known to prolong the QT interval (e.g., pentamidine, levomethadyl acetate, methadone) patients with risk factors for QT prolongation, including patients with congenital long QT syndrome, with a history of cardiac arrhythmias or other cardiac conditions, elderly patients and those with electrolyte abnormalities.

Dehydration Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of Loperamide Hydrochloride Capsules does not preclude the need for appropriate fluid and electrolyte therapy.

Gastrointestinal Disorders In general, Loperamide Hydrochloride Capsules should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. Loperamide Hydrochloride Capsules must be discontinued promptly when constipation, abdominal distention or ileus develop. Treatment of diarrhea with Loperamide Hydrochloride Capsules is only symptomatic.

Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated). Patients with AIDS treated with Loperamide Hydrochloride Capsules, 2 mg for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.

Variability in Pediatric Response Loperamide Hydrochloride Capsules should be used with special caution in pediatric patients because of the greater variability of response in this age group. Dehydration, particularly in pediatric patients less than 6 years of age, may further influence the variability of response to Loperamide Hydrochloride Capsules. Loperamide Hydrochloride Capsules is contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Clinical Trial Experience The adverse effects reported during clinical investigations of Loperamide Hydrochloride Capsules (loperamide hydrochloride) are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with Loperamide Hydrochloride Capsules were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.

The adverse events reported are summarized irrespective of the causality assessment of the investigators. 1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented in the table below. Acute Diarrhea Loperamide Hydrochloride Placebo No. of treated patients 231 236 Gastrointestinal AE% Constipation 2.6% 0.8% The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride, were: dry mouth, flatulence, abdominal cramp and colic.

2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented below in the table below. Chronic Diarrhea Loperamide Hydrochloride Placebo No. of treated patients 285 277 Gastrointestinal AE% Constipation 5.3% 0.0% Central and peripheral nervous system AE% Dizziness 1.4% 0.7% The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.

3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea The adverse events with an incidence of 1.0% or greater in patients from all studies are given in the table below. Acute Diarrhea Chronic Diarrhea All Studies a No. of treated patients 1913 1371 3740 Gastrointestinal AE% Nausea Constipation Abdominal cramps 0.7% 1.6% 0.5% 3.2% 1.9% 3.0% 1.8% 1.7% 1.4% a. All patients in all studies, including those in which it was not specified if the adverse events occurred in patients with acute or chronic diarrhea.

Postmarketing Experience The following adverse events have been reported: Cardiac disorders QT/QTc interval prolongation, Torsades de Pointes, other ventricular arrhythmias, cardiac arrest, syncope, and death (see WARNINGS, OVERDOSAGE ). Skin and subcutaneous tissue disorders Rash, pruritus, urticaria, and angioedema and extremely rare cases bullous eruption including erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with use of Loperamide Hydrochloride Capsules. Immune system disorders Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of Loperamide Hydrochloride Capsules.

Gastrointestinal disorders Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon; including toxic megacolon (see CONTRAINDICATIONS, WARNINGS ). Renal and urinary disorders Urinary retention Nervous system disorders Drowsiness, dizziness General disorders and administrative site conditions Tiredness A number of the adverse events reported during the clinical investigations and post-marketing experience with loperamide are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence).

These symptoms are often difficult to distinguish from undesirable drug effects.

🔄 Drug Interactions ~2 min read ▾

DRUG INTERACTIONS Effects of Other Drugs on Loperamide Concomitant use of Loperamide Hydrochloride Capsules with inhibitors of CYP3A4 (e.g., itraconazole) or CYP2C8 (e.g., gemfibrozil) or inhibitors of P-glycoprotein (e.g., quinidine, ritonavir) can increase exposure to loperamide. The increased systemic exposure to loperamide may increase a risk for cardiac adverse reactions especially in patients who are taking multiple CYP enzyme inhibitors, or in patients with underlying cardiac conditions (see WARNINGS ). Monitor patients for cardiac adverse reactions.

CYP3A4 Inhibitors Itraconazole Concomitant administration of multiple doses of 100 mg itraconazole twice daily, an inhibitor of both CYP3A4 and P-glycoprotein, with a single 4-mg dose of loperamide hydrochloride increased the peak plasma concentration and the systemic exposure to loperamide by 2.9-fold and 3.8-fold, respectively. CYP2C8 Inhibitors Gemfibrozil When a single 4-mg dose of loperamide hydrochloride was co-administered with 600 mg gemfibrozil, a strong inhibitor of CYP2C8, on day 3 of a 5-day treatment with gemfibrozil twice daily, the mean peak plasma concentration and the systemic exposure to loperamide was increased by 1.6-fold and 2.2-fold, respectively.

CYP3A4 and CYP2C8 Inhibitors When multiple doses of both 100 mg itraconazole and 600 mg gemfibrozil twice daily were administered with a single 4-mg dose of loperamide hydrochloride, the mean peak plasma concentration and the systemic exposure to loperamide was increased by 4.2-fold and 12.6-fold, respectively. P-glycoprotein Inhibitors Concomitant administration of a 16 mg single dose of loperamide hydrochloride with a 600 mg single dose of quinidine or ritonavir, both of which are P-glycoprotein inhibitors, resulted in a 2- to 3-fold increase in loperamide plasma concentrations.

Due to the potential for enhanced CNS adverse reactions when loperamide is co-administered with quinidine and with ritonavir, caution should be exercised when Loperamide Hydrochloride Capsules USP, 2 mg is administered at the recommended dosages (2 mg, up to 16 mg maximum daily dose) with P-glycoprotein inhibitors. Effects of Loperamide on Other Drugs Saquinavir When a single 16-mg dose of loperamide hydrochloride is coadministered with a 600 mg single dose of saquinavir, loperamide decreased saquinavir exposure by 54%, which may be of clinical relevance due to reduction of therapeutic efficacy of saquinavir.

The effect of saquinavir on loperamide is of less clinical significance. Therefore, when Loperamide Hydrochloride Capsules is given with saquinavir, the therapeutic efficacy of saquinavir should be closely monitored.

🤰 Pregnancy 171 words ▾

PREGNANCY Teratogenic Effects Teratology studies have been performed in rats using oral loperamide hydrochloride doses of 2.5, 10, and 40 mg/kg/day, and in rabbits using oral doses of 5, 20, and 40 mg/kg/day. These studies have revealed no evidence of impaired fertility or harm to the fetus at doses up to 10 mg/kg/day in rats (5 times the human dose based on body surface area comparison) and 40 mg/kg/day in rabbits (43 times the human dose based on body surface area comparison). Treatment of rats with oral doses of 40 mg/kg/day (21 times the human dose based on a body surface area comparison) produced marked impairment of fertility.

The studies produced no evidence of teratogenic activity. There are no adequate and well controlled studies in pregnant women. Loperamide Hydrochloride Capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects In a peri- and post-natal development study in rats, oral administration of 40 mg/kg/day produced impairment of growth and survival of offspring.

🧒 Pediatric Use ~1 min read ▾

PEDIATRIC USE Loperamide Hydrochloride Capsules, 2 mg is contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see CONTRAINDICATIONS ). Postmarketing cases of cardiac arrest, syncope, and respiratory depression have been reported in pediatric patients less than 2 years of age (see WARNINGS ). Pediatric patients may be more sensitive to CNS effects, such as altered mental status, somnolence, and respiratory depression, than adults.

There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with pediatric patients less than two years of age. Loperamide Hydrochloride Capsules should be used with special caution in pediatric patients because of their greater variability of response (see WARNINGS ).

Dehydration, particularly in pediatric patients less than 6 years of age, may further influence the variability of response to Loperamide Hydrochloride Capsules The safety and effectiveness of Loperamide Hydrochloride Capsules in pediatric patients with chronic diarrhea have not been established. Although Loperamide Hydrochloride Capsules has been studied in a limited number of pediatric patients with chronic diarrhea; the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established.

In case of accidental overdosage of Loperamide Hydrochloride Capsules by pediatric patients, see OVERDOSAGE for suggested treatment.

🆘 Overdosage ~2 min read ▾

OVERDOSAGE The use of higher than recommended Loperamide Hydrochloride Capsules doses may result in life-threatening cardiac, CNS and respiratory adverse reactions. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Cardiac Effects Symptoms Cases of overdosage with loperamide hydrochloride (chronic ingestion of doses ranging from 70 mg to 1600 mg daily; 4 to 100 times the recommended dose) have resulted in life-threatening cardiac adverse reactions, including QT/QTc and QRS interval prolongation, Torsades de Pointes, Brugada syndrome and other ventricular arrhythmias, syncope, cardiac arrest, and death.

Cases include patients who were abusing (using supratherapeutic doses in place of opioids to induce euphoria) or misusing (taking higher than recommended doses to control diarrhea or to prevent opioid withdrawal) loperamide. The following are representative cases that included cardiac adverse reactions: 25 year old abused loperamide and presented to the hospital on multiple occasions with symptoms of syncope, nausea, vomiting, bradycardia, hypotensive shock. The patient also experienced ventricular tachycardia, a prolonged QTc of 527 ms and QRS interval of 170 ms, frequent premature ventricular contractions, and subsequent cardiac arrest and death (elevated loperamide blood concentration of 32 ng/ml).

54 year old misused loperamide hydrochloride (up to 144 mg per day) as a self- treatment for chronic diarrhea for over 2 years. Signs of cardiac toxicity included syncope, prolonged QT of 500 ms sinus arrest with junctional escape rhythm, and polymorphic ventricular tachycardia, which required cardioversion and implantable cardioverter-defibrillator (ICD) management. 26 year old, with prior opioid abuse, presented to the hospital with recurrent syncope and developed Torsades de Pointes requiring electrical cardioversion.

An ECG revealed a sinus rhythm with a heart rate of 85 bpm and a markedly prolonged QTc interval of greater than 700 ms. The patient reported ingesting 100 to 250 mg of loperamide hydrochloride with 400 mg of cimetidine daily for several months to simulate the euphoric sensation associated with opioids. Management Consider loperamide as a possible cause of cardiac arrhythmias in patients who may have a history of opioid abuse or recent ingestion of unknown drugs and in the differential diagnosis of unstable arrhythmias, prolonged QTc or QRS intervals, and Torsades de Pointes.

If loperamide-induced cardiac toxicity is suspected, promptly discontinue the drug and initiate therapy to manage and prevent cardiac arrhythmias and serious outcomes. In many cases of loperamide overdosage, anti-arrhythmic medications (e.g., magnesium sulfate) were ineffective in resolving the arrhythmias and preventing further episodes of Torsades de Pointes. Electrical cardioversion and overdrive pacing, and isoproterenol continuous infusion were reported to manage QTc prolongation in the setting of overdose.

Laboratory Testing Loperamide serum concentrations are not widely available or clinically useful to guide patient management. CNS and Respiratory Depression Symptoms Cases of loperamide overdose (including relative overdose due to hepatic dysfunction), may cause opioid toxic effects including CNS depression (e.g. altered mental status, stupor, coordination disorders, somnolence, miosis, muscular hypertonia, respiratory depression), hypotension, urinary retention, and paralytic ileus. Pediatric patients may be more sensitive to CNS effects, including respiratory depression, than adults.

Management Loperamide non-cardiac arrhythmia overdosages should be treated as opioid overdosages. Naloxone may reverse the opioid-related toxicity, including CNS and respiratory depression, and hypotension, associated with loperamide overdosage. In adults and pediatric patients, naloxone may be administered intravenously.

Appropriate doses of naloxone, via intr…

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action In vitro and animal studies show that Loperamide Hydrochloride Capsules (loperamide hydrochloride) acts by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. Loperamide binds to the opiate receptor in the gut wall. Consequently, it inhibits the release of acetylcholine and prostaglandins, thereby reducing propulsive peristalsis, and increasing intestinal transit time.

Loperamide increases the tone of the anal sphincter, thereby reducing incontinence and urgency. Pharmacodynamics Loperamide prolongs the transit time of the intestinal contents. It reduces daily fecal volume, increases the viscosity and bulk density, and diminishes the loss of fluid and electrolytes.

Tolerance to the antidiarrheal effect has not been observed. Pharmacokinetics Absorption Plasma concentrations of unchanged drug remain below 2 ng/mL after the intake of a 2 mg capsule of Loperamide Hydrochloride Capsules. Plasma loperamide concentrations are highest approximately 5 hours after administration of the capsule and 2.5 hours after the liquid.

The peak plasma concentrations of loperamide were similar for both formulations. Distribution Based on literature information, the plasma protein binding of loperamide is about 95%. Loperamide is a P-glycoprotein substrate.

Elimination The apparent elimination half-life of loperamide is 10.8 hours with a range of 9.1 to 14.4 hours. Elimination of loperamide mainly occurs by oxidative N-demethylation. Metabolism In vitro loperamide is metabolized mainly by cytochrome P450 (CYP450) isozymes, CYP2C8 and CYP3A4, to form- N-demethyl loperamide.

In an in vitro study quercetin (CYP2C8 inhibitor) and ketoconazole (CYP3A4 inhibitor) significantly inhibited the N-demethylation process by 40% and 90%, respectively. In addition, CYP2B6 and CYP2D6 appear to play a minor role in loperamide N-demethylation. Concomitant use of Loperamide Hydrochloride Capsules with inhibitors of CYP3A4 (e.g., itraconazole) or CYP2C8 (e.g., gemfibrozil) or inhibitors of P-glycoprotein (e.g., quinidine, ritonavir) can increase exposure to loperamide (see PRECAUTIONS, Drug Interactions ).

Excretion Excretion of the unchanged loperamide and its metabolites mainly occurs through the feces.

📦 How Supplied / Storage and Handling 80 words ▾

HOW SUPPLIED Capsules - each capsule contains 2 mg of loperamide hydrochloride. The capsules have a light brown opaque cap and a light brown opaque body with an “^" over “605” imprinted radially on one segment. NDC 51407-999-01 (100 CAPSULES) NDC 51407-999-05 (500 CAPSULES) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Revised October 2021 Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336 Rx Only Printed in USA Marketed by: GSMS, Inc. Camarillo, CA 93012 USA

📋 Description 79 words ▾

DESCRIPTION Loperamide Hydrochloride Capsules USP (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl- a,a- diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Loperamide Hydrochloride Capsules USP is available in 2mg capsules. The inactive ingredients are: Magnesium stearate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, colloidal silicon dioxide.

In addition, the hard gelatin capsule also contains gelatin, black iron oxide, red iron oxide, titanium dioxide and yellow iron oxide. The black printing ink contains black iron oxide, propylene glycol, shellac, and potassium hydroxide. api

💬 Information for Patients 191 words ▾

INFORMATION FOR PATIENTS Advise patients: to take Loperamide Hydrochloride Capsules at the prescribed dosage. Use of a higher than prescribed dosage is not recommended (see WARNINGS ). Report to a healthcare facility if you or someone you are caring for taking Loperamide Hydrochloride Capsules experiences fainting episode, a rapid or irregular heartbeat or become unresponsive. with acute diarrhea, that if clinical improvement is not observed in 48 hours, discontinue Loperamide Hydrochloride Capsules and contact their healthcare provider. to contact their healthcare provider if they see blood in their stools, or if they develop a fever or abdominal distention. to use caution when driving a car or operating machinery, as tiredness, dizziness, or drowsiness may occur in the setting of diarrheal syndromes treated with Loperamide Hydrochloride Capsules.

(see ADVERSE REACTIONS ) to tell their healthcare provider about all the medications they are taking, including prescription and over-the-counter medications, vitamins and herbal supplements, especially if they take Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, antipsychotics (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), or any other drug known to prolong the QT interval (e.g., pentamidine, levomethadyl acetate, methadone).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51407-0998-01 · Golden 51421-0001-25 · Terhormon →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.