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Dextromethorphan Polistirex Extended-Release 30 mg/5mL Suspension — NDC 65162-0799-76 package photo

Dextromethorphan Polistirex Extended-Release 30 mg/5mL Suspension

by Amneal Pharmaceuticals LLC · 1 BOTTLE in 1 CARTON (65162-799-76) / 89 mL in 1 BOTTLE
NDC 65162-0799-76
🏷️ FDA NDC (as labeled) 65162-799-76 billing pads the product segment with a zero
This package
Contains89 mL in 1 bottle Pack sizes2 compare ↓
Also comes in: 148 mL 65162-0799-77
OTC 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) 65162-799-76
Product NDC 65162-799
11-digit billing NDC 65162079976
RxCUI 1373045
UNII 9D2RTI9KYH
Application # ANDA203133
SPL Set ID e0104a59-0bc2-4401-8c14-7f28499dbac6
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-08-01
Route ORAL
Dosage form SUSPENSION
Substance DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs? The FDA registers this code as 65162-799-76 — 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 → 65162-0799-76. 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 LLC
FDA applicationANDA203133 (ANDA)
Labeler code65162
First marketedAug 2017
Product typeHuman Otc Drug
Portfolio490 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

📖 What it is MedlinePlus · NLM

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It won't necessarily silence your cough entirely, but it does temporarily suppress the cough reflex and reduce how intense and frequent your cough is. It can also help reduce that...
  • What exactly does dextromethorphan do — will it stop my cough completely?
  • It depends on your child's age and the specific product. Most dextromethorphan products should not be given to children under 4 years old without a doctor's guidance. Some products...
  • This is a really important question. If your antidepressant is an MAOI (monoamine oxidase inhibitor), you absolutely cannot take dextromethorphan — not while you're on it, and not...
📖 Read our full Dextromethorphan 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 purple
FlavorGrape
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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • 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 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 1699G8679Z
    A synthetic polymer that acts as a binder and helps hold tablet or capsule ingredients together. It may also be used to improve how the medicine dissolves or is absorbed in the digestive system.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 2944357O2O
    A natural gum derived from the tragacanth shrub, used as a thickener, stabilizer, and binder in medicines. It helps create the right consistency and keeps ingredients evenly mixed throughout the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesInactive ingredients citric acid, corn oil, D&C Red No. 33, edetate disodium, ethylcellulose, FD&C Blue No. 1, flavors, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sodium polystyrene sulfonate, sucrose, tragacanth, xanthan gum Hydrochloric acid or sodium hydroxide solution, if required, to adjust the pH.

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 mLPer 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: 148 mL
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
Good Sense Cough DM 30 mg/5mL 00113-0958-21 L. 1 bottle $0.066 — Availability likely —
cough dm 30 mg/5mL 00904-6312-56 Major 1 bottle $0.066 — Availability likely —
dextromethorphan polistirex extended release 30 mg/5mL 45802-0433-21 Padagis 1 bottle $0.066 — Availability likely —
Good Neighbor Pharmacy Cough DM ER 30 mg/5mL 46122-0141-21 Amerisource 1 bottle $0.066 — Availability likely —
Leader Cough DM 30 mg/5mL 70000-0187-01 Cardinal 1 bottle $0.066 — Availability likely —
leader childrens cough dm 30 mg/5mL 70000-0195-01 Cardinal 1 bottle $0.066 — Availability likely —
Leader Cough DM 30 mg/5mL 70000-0302-01 Cardinal 1 bottle $0.066 — Availability likely —
foster and thrive 12 hour cough relief 30 mg/5mL 70677-1025-01 Strategic 1 bottle $0.066 — Availability likely —
foster and thrive 12 hour cough relief 30 mg/5mL 70677-1026-01 Strategic 1 bottle $0.066 — Availability likely —
Delsym (Dextromethorphan) 30 mg/5mL 63824-0173-63 Reckitt 1 bottle $0.102 — FDA listed —
Delsym (Dextromethorphan) 30 mg/5mL 63824-0177-63 Reckitt 1 bottle $0.102 — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8655-10 Haleon 1 bottle — — FDA listed —
Childrens Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8725-10 Haleon 1 bottle — — FDA listed —
Childrens Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8726-10 Haleon 1 bottle — — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8753-03 Haleon 1 bottle — — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8754-15 Haleon 1 bottle — — FDA listed —
Robitussin 12 Hour Cough Relief 30 mg/5mL 00031-8755-15 Haleon 1 bottle — — FDA listed —
good sense cough dm 30 mg/5mL 00113-0384-21 L. 1 bottle — — Discontinued —
Cough DM 30 mg/5mL 00363-0384-21 Walgreen 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 00363-0494-21 Walgreen 1 bottle — — Discontinued —
childrens cough dm 30 mg/5mL 00363-0899-21 Walgreen 1 bottle — — FDA listed —
up and up 12 hour cough relief 30 mg/5mL 11673-0114-28 Target 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 11822-0384-01 Rite 1 bottle — — Discontinued —
Cough DM 30 mg/5mL 11822-0494-01 Rite 1 bottle — — Discontinued —
Cough DM 30 mg/5mL 11822-0958-01 Rite 1 bottle — — Discontinued —
cough dm 30 mg/5mL 17856-6312-01 ATLANTIC 5 ml — — FDA listed —
signature care 12 hour cough relief 30 mg/5mL 21130-0012-21 Safeway 1 bottle — — FDA listed —
Signature Care Cough Relief 30 mg/5mL 21130-0520-21 Safeway 1 bottle — — FDA listed —
Cough Dm 30 mg/5mL 21130-0538-21 Safeway 1 bottle — — FDA listed —
signature care childrens 12 hour cough relief 30 mg/5mL 21130-0890-21 Safeway 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 30142-0384-21 Kroger 1 bottle — — FDA listed —
cough dm 30 mg/5mL 30142-0494-21 Kroger 1 bottle — — FDA listed —
TopCare Cough DM 30 mg/5mL 36800-0494-21 Topco 1 bottle — — FDA listed —
Topcare Cough DM 30 mg/5mL 36800-0552-21 Topco 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 37808-0384-21 H 1 bottle — — FDA listed —
equaline cough dm 30 mg/5mL 41163-0384-21 United 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 41250-0384-28 Meijer 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 41250-0494-28 Meijer 1 bottle — — FDA listed —
cough dm childrens 30 mg/5mL 41250-0899-28 Meijer 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 41250-0958-28 Meijer 1 bottle — — FDA listed —
CareOne Cough DM 30 mg/5mL 41520-0384-21 American 1 bottle — — FDA listed —
CareOne Cough DM 30 mg/5mL 41520-0958-21 American 1 bottle — — FDA listed —
cough dm 30 mg/5mL 42507-0384-21 HyVee 1 bottle — — FDA listed —
cough dm 30 mg/5mL 42507-0494-21 HyVee 1 bottle — — FDA listed —
Equate Cough DM 30 mg/5mL 49035-0384-21 Wal-Mart 1 bottle — — FDA listed —
equate cough dm 30 mg/5mL 49035-0899-28 Wal-Mart 1 bottle — — FDA listed —
Delsym 30 mg/5mL 50090-0224-00 A-S 1 bottle — — FDA listed —
12 Hr Relief Cough Dm 30 mg/5mL 51316-0263-21 CVS 1 bottle — — FDA listed —
Childrens 12 Hr Cough Relief 30 mg/5mL 51316-0429-28 CVS 1 bottle — — FDA listed —
DG Health Cough DM 30 mg/5mL 55910-0384-21 Dolgencorp 1 bottle — — FDA listed —
DG Health Cough DM 30 mg/5mL 55910-0958-21 Dolgencorp, 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 56062-0384-21 Publix 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0610-05 Aurohealth 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0611-05 Aurohealth 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0617-05 Aurohealth 1 bottle — — FDA listed —
Dextromethorphan Polistirex 30 mg/5mL 58602-0618-05 Aurohealth 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 59779-0384-21 CVS 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 59779-0709-21 CVS 1 bottle — — FDA listed —
Cough DM 30 mg/5mL 59779-0958-21 CVS 1 bottle — — FDA listed —
Delsym 30 mg/5mL 63824-0171-22 Reckitt 1 cello — — FDA listed —
Delsym 30 mg/5mL 63824-0175-22 Reckitt 1 cello — — FDA listed —
Dextromethorphan Polistirex Extended-Release 30 mg/5mL 65162-0700-76 Amneal 1 bottle — — FDA listed —
Dextromethorphan Polistirex Extended-Release 30 mg/5mLthis 65162-0799-76 Amneal 1 bottle — — FDA listed —
dextromethorphan polistirex extended release 30 mg/5mL 72162-2281-02 Bryant 1 bottle — — FDA listed —
basic care cough dm 30 mg/5mL 72288-0384-28 Amazon.com 1 bottle — — FDA listed —
basic care cough dm 30 mg/5mL 72288-0494-28 Amazon.com 1 bottle — — FDA listed —
basic care childrens cough dm 30 mg/5mL 72288-0899-28 Amazon.com 1 bottle — — FDA listed —
basic care childrens cough dm 30 mg/5mL 72288-0958-28 Amazon.com 1 bottle — — FDA listed —
cough dm 30 mg/5mL 72288-0652-28 Amazon.com 1 bottle — — 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

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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
65162-0799-76 You're viewing this 1 BOTTLE in 1 CARTON (65162-799-76) / 89 mL in 1 BOTTLE 2017-08-01 Active
65162-0799-77 1 BOTTLE in 1 CARTON (65162-799-77) / 148 mL in 1 BOTTLE 2017-08-01 Active

Pack size FAQ

What quantity is in NDC 65162-0799-76?
NDC 65162-0799-76 is listed by the FDA — 1 bottle in 1 carton / 89 ml in 1 bottle.
What NDC number is used to bill for this package of Dextromethorphan Polistirex Extended-Release 30 mg/5mL Suspension?
Bill NDC 65162-0799-76 — the 11-digit billing format is 65162079976. 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 ✓ 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 — 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 65162-799-76, 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: 65162-0799-76, written without dashes as 65162079976. 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 65162-0799-76, the first segment (65162) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (0799) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (76) 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 1 other package presentation of this same product, including 1 bottle (65162-0799-77). 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 34 words ▾

INDICATIONS AND USAGE Uses Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

⏱️ Dosage and Administration 128 words ▾

DOSAGE AND ADMINISTRATION Directions shake bottle well before use measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use Other information each 5 mL contains: sodium 7 mg store at 20° to 25°C (68° to 77°F) dosing cup provided

⚠️ Warnings 2 words ▾

WARNINGS Warnings

🧪 Active Ingredient 19 words ▾

OTC - ACTIVE INGREDIENT Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

🧪 Inactive Ingredients 50 words ▾

INACTIVE INGREDIENT Inactive ingredients citric acid, corn oil, D&C Red No. 33, edetate disodium, ethylcellulose, FD&C Blue No. 1, flavors, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sodium polystyrene sulfonate, sucrose, tragacanth, xanthan gum Hydrochloric acid or sodium hydroxide solution, if required, to adjust the pH.

🎯 Purpose 6 words ▾

OTC - PURPOSE Purpose Cough suppressant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65162-0791-08 · Amneal 65162-0801-14 · 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.