EXPECTORANT COUGH CHILDRENS- dextromethorphan hydrobromide and guaifenesin liquid 
Western Family Foods 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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Western Family Children’s Expectorant Cough Drug Facts

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Purpose

Cough suppressant

Expectorant

Uses

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

Warnings

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 the child has

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

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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

store at 20-25 oC (68-77 oF)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

Principal Display Panel

FOR AGES 4 TO 12

Children’s Expectorant Cough

GUAIFENESIN 100mg – EXPECTORANT

DEXTROMETHORPHAN HBr 5mg – COUGH SUPPRESSANT

COUGH

CHEST CONGESTION

LOOSENS MUCUS

ALCOHOL-FREE

Gluten Free

CHERRY FLAVOR LIQUID

COMPARE TO ACTIVE INGREDIENTS OF CHILDREN’S MUCINEX® COUGH

Children's Expectorant Cough Carton Image 1
Children's Expectorant Cough Carton Image 2
EXPECTORANT COUGH  CHILDRENS
dextromethorphan hbr, guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-419
Route of Administration ORAL DEA Schedule     
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color RED (Dark Red) Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55312-419-26 1 in 1 CARTON
1 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/26/2007
Labeler - Western Family Foods Inc (192166072)

Revised: 9/2012
Document Id: 4b42a2b5-ca17-450f-bdb4-f6792d9ad523
Set id: 4b42a2b5-ca17-450f-bdb4-f6792d9ad523
Version: 1
Effective Time: 20120927
 
Western Family Foods Inc