BREACOLD CHILDREN- guaifenesin, dextromethorphan hbr liquid

Breacold Children by

Drug Labeling and Warnings

Breacold Children by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

• 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:

• This product for persistent or chronic cough, such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
• 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.

KEEP OUT OF REACH OF CHILDREN

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BREACOLD CHILDREN 
guaifenesin, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-007-04	1 in 1 CARTON	02/21/2012
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/21/2012

Labeler - Menper Distributors, Inc. (101947166)