SEVERE CONGESTION AND COUGH MAX- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

SEVERE CONGESTION and COUGH MAX by

Drug Labeling and Warnings

SEVERE CONGESTION and COUGH MAX by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

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

PURPOSE

Purpose

Dextromethorphan HBr    Cough suppressant
Guaifenesin                     Expectorant
Phenylephrine                 Nasal Decongestant

INDICATIONS & USAGE

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

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.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions
take only as recommended
use dosage cup
mL =milliliter
do not take more than 6 doses in any 24-hour period

• 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

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

QUESTIONS

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

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

INGREDIENTS AND APPEARANCE

SEVERE CONGESTION AND COUGH MAX 
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-517
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-517-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/30/2024

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-517)