BREACOLD CHILDREN- 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 15mL tsp)

Guaifenesin 100 mg………………………………Expectorant

Dextromethorphan HBr 10 mg……………………Cough suppressant

purpose

Expectorant

Cough Suppressant

Uses

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the commun cold and help loosen phleg, (mucus) and thin bronchial secretions to make coughs more productive.

Warnings Do not exceed recommended dosage.

Do not use:

Keep out of reach of children.

If you are 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

Children 6 to under                                                  1 teaspoonful (5 mL)

12 years of age..................................................... every 4 hours

Children 2 to under                                                   1/2 teaspoonful (2.5 mL)

6 years of age....................................................... every 4 hours

Children under 2 years of age.................................. consult your doctor

Other information

Store this product between 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions?

Call 1-800-560-5223 M-F 9 AM to 4 PM Eastern.

Brea-Cold Children

BREACOLD CHILDREN 
guaifenesin, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
RASPBERRY (UNII: 4N14V5R27W)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53145-007-041 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: 8273b206-18ec-4768-b844-dd9dfd1fb073
Set id: c3d2f57f-7cde-481e-92d8-aaaab0832811
Version: 3
Effective Time: 20220218
 
Menper Distributors, Inc.