FDA.reportPublic FDA data

SEVERE CONGESTION and COUGH MAX

Manufacturer
AptaPharma Inc.
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:11

Label at a glance#

ProductSEVERE CONGESTION and COUGH MAX
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts


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

OTC - PURPOSE SECTION

Purpose

Dextromethorphan HBr    Cough suppressant
Guaifenesin                     Expectorant
Phenylephrine                 Nasal Decongestant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

Maximum Strength Max Severe Congestion & Cough

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

517 6 Oz517 6 Oz

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043543dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN1
1043543dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
1043543dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY1
1043543dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
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e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
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76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
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9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-517-25SEVERE CONGESTION and COUGH MAX177 mL in 1 BOTTLELIQUID1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-517SEVERE CONGESTION AND COUGH MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.]1Current NDC, 1 package rows20240202_17a07d2d-f2da-4e51-9a77-6f0c174987bb.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-51776281-517-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.17a07d2d-f2da-4e51-9a77-6f0c174987bb2024-01-31WarningsExact identifier
ndc (package): 76281-517-25
ndc (product): 76281-517
ndc11 (package): 76281051725
spl id: 1758bfe6-e9c6-445d-9a3c-55c24ba5bde1
spl set id: 17a07d2d-f2da-4e51-9a77-6f0c174987bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.