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

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 Best Choice, 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 HCl ................. Nasal Decongestant

INDICATIONS & USAGE

Uses

■ helps loosen pjlegm (mucus)
and thin bronchial secretions
to drain bronchial tubes
■ Temporarily relieves these symptoms ocurring 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

When using this product, do not use
more than directed

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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 9:30 AM to 4:30 PM EST at 1-877-798-5944

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Product Label: Best Choice® Max Severe Congestion & Cough

Best Choice®

MAXIMUM STRENGTH

Max Severe Congestion & Cough

6 FL OZ (177 mL)

PROUDLY DISTRIBUTED BY:

VALUE MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

Compare to the active ingredients in

Mucinex® FAST-MAX™ Severe

Congestion & Cough*

*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 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-517
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: 63941-517-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/01/2025

Labeler - Best Choice (868703513)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(63941-517)