BREACOLD ADULT- guaifenesin, dextromethorphan hbr liquid 
Menper Distributors, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients (in each 10mL tsp)

Guaifenesin 200 mg………………………………Expectorant

Dextromethorphan HBr 20 mg…………………….Cough suppressant

Purpose

Expectorant

Cough Suppressant

Uses

Temporarily relieves cough due to minor throat ands bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Do not exceed recommended dosage.

A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Do not use:

Keep out of reach of children.

If  pregnant or breast-feeding

ask a health professional before use. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions: Do not exceed 6 doses in 24 hours.

 Age Dose
 Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
 Children under 12 years of age Do not use

Other information

Inactive ingredients

Citric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben,raspberry flavor, sucrose, water

breacold adult

BREACOLD ADULT 
guaifenesin, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-040
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
RASPBERRY (UNII: 4N14V5R27W)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-040-041 in 1 CARTON02/21/2012
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/21/2012
Labeler - Menper Distributors, Inc. (101947166)

Revised: 2/2022
Document Id: 0aeb98ab-943c-4f17-a025-89e7a4f85194
Set id: 69878145-6ac2-44c1-8eb6-56df46dd89f1
Version: 9
Effective Time: 20220218
 
Menper Distributors, Inc.