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SEVERE CONGESTION and COUGH MAX Dextromethorphan HBr, GUaifenesin, Phenylephrine HCL 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Liquid, 177 mL — NDC 76281-517-25 (Billing 76281-0517-25)

by AptaPharma Inc. · 177 mL in 1 BOTTLE

This is a package of 177 mL of SEVERE CONGESTION and COUGH MAX Dextromethorphan HBr, GUaifenesin, Phenylephrine HCL 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Liquid from AptaPharma Inc., marketed since Jan 2024 and currently FDA-listed. It is this product's only package size.

NDC 76281-0517-25
🏷️ FDA NDC (as labeled) 76281-517-25 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76281-517-25
Product NDC 76281-517
11-digit billing NDC 76281051725
RxCUI 1043543
UNII 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Application # M012
SPL Set ID 17a07d2d-f2da-4e51-9a77-6f0c174987bb
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-30
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1043543
Why two NDCs? The FDA registers this code as 76281-517-25 — 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 → 76281-0517-25. 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.

Clinical

🧪 What is this product?

This is an over-the-counter liquid cough and cold product taken by mouth. It contains dextromethorphan, a cough suppressant typically used to reduce coughing, along with guaifenesin, an expectorant commonly used to help thin mucus and make coughs more productive. Phenylephrine is a nasal decongestant typically used to help relieve congestion. This product combines these three ingredients in a single liquid formulation marketed for severe congestion and cough relief.

Supplement & herbal interactions

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

Pricing

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

Price systemPer 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.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76281-0517-25 You're viewing this Main listing 177 mL in 1 BOTTLE 2024-01-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Childrens Multi Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 70000-0629-01 CARDINAL 1 bottle $0.047 — Availability likely —
Mucinex Fast-Max Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63824-0540-66 Reckitt 180 ml $0.060 — FDA listed —
Mucinex Childrens Multi-Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0949-01 Reckitt 1 bottle $0.070 — FDA listed —
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0956-64 Reckitt 1 bottle $0.070 — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0337-06 Walgreens 177 ml — — FDA listed —
Mucus Congestion and Cough Relief Childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 00363-0512-06 Walgreens 1 bottle — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0681-06 Walgreens 177 ml — — FDA listed —
Childrens Mucus Cough and Congestion Relief 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 00363-1056-88 Walgreen 1 bottle — — FDA listed —
Walgreen Maximum Strength Severe Congestion and cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-7389-09 WALGREENS 266 ml — — FDA listed —
Walgreens Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-7760-06 WALGREEN 180 ml — — FDA listed —
Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-8004-45 Walgreen 177 ml — — FDA listed —
Childrens Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 00363-9057-36 Walgreen 1 bottle — — FDA listed —
Mucus Relief Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0337-06 TARGET 177 ml — — FDA listed —
Up and Up maximum Strength fast mucus relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0738-06 Target 177 ml — — FDA listed —
SIGNATURE CARE Childrens Multi Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 21130-0162-04 SAFEWAY 1 bottle — — FDA listed —
Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 21130-0738-06 SAFEWAY 180 ml — — FDA listed —
Kroger Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 30142-0738-06 KROGER 180 ml — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 36800-0037-06 TOP 177 ml — — FDA listed —
H E B MAX SEVERE CONGESTION and COUGH Maxium Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 37808-0317-25 H 177 ml — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0047-06 United 177 ml — — FDA listed —
maximum strength mucus relief severe congestion and cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0738-06 SuperValu 180 ml — — FDA listed —
Childrens Multi-Symptom Cold 5 mg/5mL; 2.5 mg/5mL; 100 mg/5mL 41226-0937-05 Kroger 1 bottle — — FDA listed —
Meijer Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41250-0446-06 MEIJER, 180 ml — — FDA listed —
Maximum Strength Mucus Relief Severe Congestion and Cough Cooling Menthol 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41250-0776-06 MEIJER 180 ml — — FDA listed —
Childrens Multi-symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 49035-0715-03 Wal-Mart 118 ml — — FDA listed —
Maximum Strength Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0774-06 Wal-Mart 180 ml — — FDA listed —
Maximum Strength Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0976-06 Wal-Mart 180 ml — — FDA listed —
Tukol MAX ACTION Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 50066-0517-25 Genomma 177 ml — — FDA listed —
Severe Congestion and Cough Relief Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 50844-0004-45 L.N.K. 177 ml — — FDA listed —
Childrens Multi Symptom Cold Very Berry 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 51316-0815-03 CVS 118 ml — — FDA listed —
Childrens Tussnex Multi-symptom cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 53041-0615-03 Guardian 1 bottle — — FDA listed —
Tussnex FM Severe cough and congestion 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53041-0617-58 Guardian 177 ml — — FDA listed —
Mucosan Severe Multi-Symptom 10 mg/20mL; 20 mg/20mL; 400 mg/20mL 53145-0697-06 Menper 1 bottle — — FDA listed —
SEVERE CONGESTION and COUGH MAX 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53942-0517-25 DeMoulas 177 ml — — FDA listed —
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53943-0517-25 Discount 177 ml — — FDA listed —
Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55319-0204-45 Family 177 ml — — FDA listed —
SanaTos Turbo Max Strength 10 mg/20mL; 20 mg/20mL; 400 mg/20mL 55758-0322-06 Pharmadel 177 ml — — FDA listed —
Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0037-09 Dolgencorp, 266 ml — — FDA listed —
Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0537-06 Dolgencorp, 177 ml — — FDA listed —
Childrens Mucinex Multi-Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0282-22 Reckitt 1 cello — — Discontinued —
Mucinex Childrens Cough and Congestion 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 63824-0947-11 Reckitt 1 bottle — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63868-0745-06 QUALITY 177 ml — — FDA listed —
Severe Congestion and Cough Max 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63941-0517-25 Best 177 ml — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 68163-0738-09 Raritan 266 ml — — FDA listed —
Mucus Relief Severe Congestion and Cough Maximum Strength 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69256-0337-06 Harris 177 ml — — FDA listed —
Cold Childrens, Multi Symptom 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 69842-0570-88 CVS 1 bottle — — FDA listed —
Congestion and Cough Childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 69842-0756-88 CVS 1 bottle — — FDA listed —
CVS Maximum Strength Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0767-06 CVS 180 ml — — FDA listed —
Severe Cough and Congestion 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0942-45 CVS 177 ml — — FDA listed —
AMAZON Childrens Multi Symptom Cold 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 72288-0649-04 AMAZON.COM 1 bottle — — FDA listed —
Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 76162-0040-45 TOPCO 177 ml — — FDA listed —
Mucus Relief Childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 76162-0057-88 TOPCO 1 bottle — — FDA listed —
SEVERE CONGESTION and COUGH MAX 20 mg/20mL; 400 mg/20mL; 10 mg/20mLthis 76281-0517-25 AptaPharma 177 ml — — FDA listed —
Multi-Symptom Cold childrens 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 79903-0176-06 WALMART 1 bottle — — FDA listed —
Childrens Multi-symptom Cold Daytime 5 mg/5mL; 100 mg/5mL; 2.5 mg/5mL 79903-0270-03 Wal-Mart 1 bottle — — FDA listed —
Mucus Relief Severe Congestion and Cough 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 83324-0077-06 Chain 177 ml — — FDA listed —
QCH Maximum Strength Mucus Relief 617 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 83324-0144-06 Chain 177 ml — — FDA listed —
Maximum Strength Mucus Relief 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 42507-0617-58 Hyvee 177 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 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 WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesInactive ingredients Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

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.

Manufacturer & labeler

LabelerAptaPharma Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code76281
First marketedJan 2024
Product typeHuman Otc Drug
Portfolio29 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.

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

Uses ● helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes ● temporarily relieves these symptoms occurring with a cold: ● cough due to minor throat and bronchial irritation ● nasal congestion

⏱️ Dosage and Administration 48 words ▾

Directions • take only as recommended • use dosage cup • mL =milliliter • do not take more than 6 doses in any 24-hour period Age Dose Adults & children 12 years and older 20 mL every 4 hours Children under 12 years of age Do not use

⚠️ Warnings 191 words ▾

Warnings • Do not use ● 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. • For children under 12 years of age Ask a doctor before use if you have ● heart disease ● thyroid disease ● high blood pressure ● diabetes ● trouble urinating due to an enlarged prostate gland ● cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema ● cough that occurs with too much phlegm (mucus) When using this product ● do not use more than directed Stop use and ask a doctor if ●nervousness, dizziness or sleeplessness occur ● symptoms do not get better within 7 days or are accompanied by a fever ● cough comes back, or occurs with fever, rash or persistent headache.

These could be signs of a serious condition. If pregnant or breast feeding , ask a health professional before use.

🧪 Active Ingredient 19 words ▾

Drug Facts Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

🎯 Purpose 10 words ▾

Purpose Dextromethorphan HBr Cough suppressant Guaifenesin Expectorant Phenylephrine Nasal Decongestant

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Other Information 23 words ▾

Other information • each 20 mL contains: sodium 10 mg • dosage cup provided • store between 15-30°C (59-86°F) • do not refrigerate

📄 Questions or Comments 10 words ▾

Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

📄 Package Label / Principal Display Panel 115 words ▾

Maximum Strength Max Severe Congestion & Cough AP SAFE ® NDC 76281-517-25 Compare to Mucinex ® FAST-MAX™ Severe Congestion & Cough Active ingredients* Maximum Strength Max Severe Congestion & Cough Dextromethorphan HBr/ Cough Suppressant Guaifenesin /Expectorant Phenylephrine HCI / Nasal Decongestant Congestion& Cough Relief of: • Cough • Thins & Loosens Mucus • Nasal & Chest Congestion Adults- For Ages 12 and over 6 FL OZ ( 177 mL) DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Manufactured by: AptaPharma Inc., 1533 Union Ave.

Pennsauken, NJ 08110 This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex ® FAST-MAX™ Severe Congestion & Cough. res 517 6 Oz

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 AptaPharma Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AptaPharma 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 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.
← 76281-0515-25 · AptaPharma 76281-0519-24 · AptaPharma →
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.