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Guaifenesin and Dextromethorphan HBr 1200 mg; 60 mg Tablet, Extended Release, 30-count

by Amneal Pharmaceuticals LLC · 1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE
NDC 65162-0039-03
🏷️ FDA NDC (as labeled) 65162-039-03 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also comes in: 10 tablets 65162-0039-17 60 tablets 65162-0039-06
OTC Generic On market Non-controlled
🗂️ Data synced Sep 17, 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) 65162-039-03
Product NDC 65162-039
11-digit billing NDC 65162003903
RxCUI 1099074
UNII 495W7451VQ, 9D2RTI9KYH
UPC 0365162039030
Application # ANDA209692
SPL Set ID cfdbcdb0-531a-4d95-ac5d-64d6d034b252
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-01
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs? The FDA registers this code as 65162-039-03 — 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 → 65162-0039-03. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor 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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS OF NEW YORK LLC
FDA applicationANDA209692 (ANDA)
Labeler code65162
First marketedNov 2018
Product typeHuman Otc Drug
Portfolio472 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

📗 Our plain-language guide HelloPharmacist
  • The two ingredients tackle your symptoms from different angles. Guaifenesin is an expectorant — it helps thin and loosen the mucus in your chest so you can cough it up more easily....
  • What exactly does this combination do — why are two ingredients needed?
  • It depends on which antidepressant you're taking. If it's a type called an MAOI — which includes certain older antidepressants and some medications for Parkinson's disease — you sh...
  • Can I take this if I'm on an antidepressant?
📖 Read our full Dextromethorphan / Guaifenesin 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.

🧪 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 F68VH75CJC
    A synthetic polymer made from acrylic acid that thickens and stabilizes liquid or gel formulations. It's used as a gelling agent and emulsifier to create the desired texture and consistency in topical medicines.
  • 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

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

The official label also statescarbomer, colloidal silicon dioxide, D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 tablets 60 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Maximum Strength Guaifenesin DM 60 mg/1; 1200 mg 00536-1213-88 Rugby 14 tablets $0.546 — Availability likely —
Rugby Mucus Relief Dm Er 1200 mg/1; 60 mg 00536-1447-88 Rugby 14 tablets $0.546 — Availability likely —
good neighbor pharmacy mucus dm 1200 mg/1; 60 mg 46122-0637-03 Amerisource 28 tablets $0.546 — Availability likely —
Mucus Relief DM Extended Release Caplets 60 mg/1; 1200 mg 70000-0464-01 Cardinal 28 tablets $0.546 — Availability likely —
Mucus Relief DM 60 mg/1; 1200 mg 70677-1049-01 Strategic 1 tablet $0.546 — Availability likely —
Mucus Relief DM 60 mg/1; 1200 mg 83324-0137-14 QUALITY 1 tablet $0.546 — Availability likely —
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief 60 mg/1; 1200 mg 00031-8765-04 Haleon 4 tablets — — FDA listed —
good sense mucus dm 1200 mg/1; 60 mg 00113-0812-03 L 1 tablet — — FDA listed —
Mucus Relief DM Extended Release Caplets Maximum Strength 60 mg/1; 1200 mg 00363-0437-14 Walgreens 14 tablets — — FDA listed —
Maximum Strength Mucus Relief DM 1200 mg/1; 60 mg 00363-0510-65 WALGREEN 7 tablets — — FDA listed —
mucus relief dm 1200 mg/1; 60 mg 00363-6812-30 Walgreen 28 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 11673-0267-05 Target 14 tablets — — FDA listed —
mucus relief DM MAX 1200 mg/1; 60 mg 11822-1812-00 Rite 14 tablets — — FDA listed —
Mucus Relief DM Maximum Strength 60 mg/1; 1200 mg 11822-7340-04 Rite 42 tablets — — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide HBR 1200 mg/1; 60 mg 11822-9996-01 RITE-AID 14 tablets — — FDA listed —
Mucus Relief DM MAXIMUM STRENGTH 1200 mg/1; 60 mg 21130-0989-03 Better 7 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 30142-0275-05 KROGER 7 tablets — — FDA listed —
Guaifenesin And Dextromethorphan Hbr 1200 mg/1; 60 mg 30142-0963-14 Kroger 14 tablets — — FDA listed —
Topcare Mucus DM 1200 mg/1; 60 mg 36800-0592-30 Topco 28 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 37808-0730-42 H 42 tablets — — FDA listed —
mucus relief dm 60 mg/1; 1200 mg 37808-0812-66 H 14 tablets — — Discontinued —
Mucus Relief DM 60 mg/1; 1200 mg 37808-0834-14 H 14 tablets — — FDA listed —
Equaline Mucus DM 1200 mg/1; 60 mg 41163-0781-66 United 14 tablets — — FDA listed —
mucus dm 1200 mg/1; 60 mg 41250-0812-30 Meijer 28 tablets — — Discontinued —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 41415-0999-14 PUBLIX 14 tablets — — FDA listed —
mucus dm 60 mg/1; 1200 mg 42507-0812-66 HyVee 14 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBR 1200 mg/1; 60 mg 43598-0115-28 Dr. 7 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBR 1200 mg/1; 60 mg 43598-0232-37 Dr. 14 tablets — — FDA listed —
Mucus DM 1200 mg/1; 60 mg 46122-0420-03 Amerisource 7 tablets — — FDA listed —
Mucus Relief DM Extended Release Caplets 60 mg/1; 1200 mg 49035-0824-28 EQUATE 28 tablets — — FDA listed —
Maximum Strength Mucus Relief DM 1200 mg/1; 60 mg 49035-0956-61 Wal-Mart 28 tablets — — FDA listed —
Mucus Relief DM Extended Release Caplets 60 mg/1; 1200 mg 50090-6020-00 A-S 14 tablets — — FDA listed —
Mucinex DM Maximum Strength 1200 mg/1; 60 mg 50090-6549-00 A-S 14 tablets — — FDA listed —
Good Sense Mucus Dm 1200 mg/1; 60 mg 50090-7258-00 A-S 14 tablets — — FDA listed —
Rugby Mucus Relief Dm Er 1200 mg/1; 60 mg 50090-7891-00 A-S 14 tablets — — FDA listed —
Maximum Strength Cough And Congestion Extended Release 1200 mg/1; 60 mg 51316-0060-65 CVS 7 tablets — — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 1200 mg/1; 60 mg 51316-0600-70 CVS 14 tablets — — FDA listed —
Mucus Relief Dm 1200 mg/1; 60 mg 51316-0671-55 CVS 42 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 51660-0110-54 OHM 14 tablets — — FDA listed —
Exchange Select Mucus DM 1200 mg/1; 60 mg 55301-0812-66 Army 14 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 55319-0734-07 Family 1 tablet — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 55319-0741-14 Family 1 tablet — — FDA listed —
DG health mucus dm 1200 mg/1; 60 mg 55910-0575-03 Dolgencorp, 1 tablet — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 58602-0715-05 Aurohealth 14 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 58602-0825-06 Aurohealth 7 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 58602-0849-11 Aurohealth 7 tablets — — FDA listed —
Mucus Relief DM 1200 mg/1; 60 mg 60000-0057-65 Ahold 14 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 63304-0110-54 SUN 14 tablets — — FDA listed —
Mucinex DM Maximum Strength 1200 mg/1; 60 mg 63824-0072-02 Reckitt 1 tablet — — FDA listed —
Mucus Relief DM Extended Release Caplets 60 mg/1; 1200 mg 63868-0870-14 QUALITY 14 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 63941-0734-14 Best 14 tablets — — FDA listed —
kirkland signature mucus dm 60 mg/1; 1200 mg 63981-0812-01 Costco 84 tablets — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mgthis 65162-0039-03 Amneal 30 tablets — — FDA listed —
Mucus Relief DM Expectorant and Cough Suppressant Maximum Strength 1200 mg/1; 60 mg 67091-0315-14 Winco 7 tablets — — FDA listed —
Mucus Relief DM Maximum Strength 60 mg/1; 1200 mg 67091-0345-14 WinCo 14 tablets — — FDA listed —
Mucus Relief DM Maximum Strength 60 mg/1; 1200 mg 68016-0674-14 Chain 14 tablets — — FDA listed —
members mark mucus relief dm 1200 mg/1; 60 mg 68196-0812-45 Sam's 56 tablets — — FDA listed —
Members Mark Mucus Relief DM 1200 mg/1; 60 mg 68196-0999-56 SAM'S 14 tablets — — FDA listed —
Berkley and Jensen Mucus Relief DM 1200 mg/1; 60 mg 68391-0812-45 BJWC 56 tablets — — FDA listed —
Maximum Strength Mucus DM Extended Release 1200 mg/1; 60 mg 69842-0059-10 CVS 7 tablets — — FDA listed —
mucus dm extended release 1200 mg/1; 60 mg 69842-0812-30 CVS 28 tablets — — Discontinued —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 71179-0011-21 VESPYR 7 tablets — — FDA listed —
Mucus Relief DM 1200 mg/1; 60 mg 72036-0980-65 Harris 7 tablets — — FDA listed —
basic care mucus dm 1200 mg/1; 60 mg 72288-0812-55 Amazon.com 42 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 72476-0734-14 Care 14 tablets — — FDA listed —
Mucus Relief - Dm Maximum Strength 60 mg/1; 1200 mg 73581-0405-98 YYBA 98 tablets — — FDA listed —
Mucus Relief - Dm Maximum Strength 60 mg/1; 1200 mg 73581-0406-01 YYBA 100 tablets — — FDA listed —
Guaifenesin And Dextromethorphan Hbr 1200 mg/1; 60 mg 76162-0032-56 TOPCO 7 tablets — — FDA listed —
Mucus Relief DM 60 mg/1; 1200 mg 81522-0734-14 FSA 1 tablet — — FDA listed —
Guaifenesin and Dextromethorphan HBr 1200 mg/1; 60 mg 85766-0046-28 Sportpharm 7 tablets — — 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65162-0039-03 You're viewing this 1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 2018-11-01 Active
65162-0039-06 1 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 2018-11-01 Active
65162-0039-17 2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2018-11-01 Active

Pack size FAQ

What quantity is in NDC 65162-0039-03?
NDC 65162-0039-03 is a 30-count package — 1 bottle in 1 carton / 30 tablet, extended release in 1 bottle.
What is the difference between NDC 65162-0039-03 and NDC 65162-0039-06?
Both are Guaifenesin and Dextromethorphan HBr 1200 mg; 60 mg Tablet, Extended Release — the drug itself is identical. NDC 65162-0039-03 is the 30-count package, while NDC 65162-0039-06 is the 60 tablets package.
What NDC number is used to bill for this package of Guaifenesin and Dextromethorphan HBr 1200 mg; 60 mg Tablet, Extended Release?
Bill NDC 65162-0039-03 — the 11-digit billing format is 65162003903. 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

Over-the-counter (OTC) 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 — Not published for this NDC No photo available yet for this listing.
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 65162-039-03, 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: 65162-0039-03, written without dashes as 65162003903. 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 65162-0039-03, the first segment (65162) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0039) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Amneal Pharmaceuticals LLC. 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 2 other package presentations of this same product, including 10 tablets (65162-0039-17), 60 tablets (65162-0039-06). 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?
Amneal Pharmaceuticals LLC 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 56 words ▾

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

⏱️ Dosage and Administration 58 words ▾

Directions 1200 mg/60 mg do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours. children under 12 years of age: do not use

⚠️ Warnings 165 words ▾

Warnings Do not use for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

🧪 Active Ingredient 19 words ▾

Active ingredient(s) (in each extended-release tablet) Active ingredient (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 1200 mg

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients carbomer, colloidal silicon dioxide, D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc

🎯 Purpose 9 words ▾

Purpose Guaifenesin - Expectorant Dextromethorphan HBr - Cough suppressant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65162-0038-03 · Amneal 65162-0045-03 · Amneal →
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.