CHILDRENS COUGH- dextromethorphan hbr, guaifenesin liquid

Childrens Cough by

Drug Labeling and Warnings

Childrens Cough by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS (in each 5 mL)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

PURPOSE

Cough suppressant
Expectorant

USE(S)

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily relieves:
• cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
• the impulse to cough to help your child get to sleep 
• the intensity of coughing

WARNING

.

DO NOT USE

in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

ASK A DOCTOR BEFORE USE IF YOU HAVE

• persistent or chronic cough such as occurs with asthma 
• cough that occurs with too much phlegm (mucus)

STOP USE AND A ASK DOCTOR IF

•  cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness. 

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away

DIRECTIONS

• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• do not use dosing cup with other products
• mL=milliliter

• Age: Dose
• children 6 years to under 12 years: 5 mL-10 mL; every 4 hours
• children 4 years to under 6 years: 2.5 mL - 5 mL; every 4 hours
• children under 4 years: do not use

OTHER INFORMATION

• each 5 mL contains: potassium 5 mg, sodium 5 mg
• store between 20 to 25°C (68 to 77°F)
• do not refrigerate
• dosing cup provided

INACTIVE INGREDIENTS

citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

QUESTIONS?

1-888-287-1915

PRINCIPAL DISPLAY PANEL

NDC: 49035-773-03

equate
Compare to Children's Mucinex Cough active ingredients*
children's 
COUGH LIQUID
Dextromethorphan HBr 5mg
Cough Suppressant

Guaifenesin 100 mg

Expectorant

AGES 4 TO 12 YEARS

• Controls cough
• Thins and Loosens Mucus
• Relieves chest congestion
• Non-Drowsy
• Alcohol Free
• Cherry Flavored

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS COUGH 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-773
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-773-03	1 in 1 CARTON	08/01/2017
1		118 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	08/01/2017

Labeler - Wal-Mart Stores, Inc. (051957769)