12 HOUR COUGH RELIEF- dextromethorphan hydrobromide suspension 
Western Family Foods Inc

----------

Western Family 12 Hour Cough Relief Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Purpose

Cough suppressant

Uses

temporarily relieves

cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the impulse to cough to help you get to sleep

Warnings

Do not use

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.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Ask a doctor before use if you have

chronic cough that lasts as occurs with smoking, asthma or emphysema
cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

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

shake bottle well before use
measure only with dosing cup provided. Do not use dosing cup with other products.
dose as follows or as directed by doctor
mL = milliliter

adults and children 12 years of age and over

10 mL every 12 hours, not to exceed 20 mL in 24 hours

children 6 to under 12 years of age

5 mL every 12 hours, not to exceed 10 mL in 24 hours

children 4 to under 6 years of age

2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

children under 4 years of age

do not use

Other information

each 5 mL contains: sodium 5 mg
store at 20° to 25°C (68° to 77°F)
dosing cup provided

Inactive Ingredients

D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

12 HOUR COUGH RELIEF

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION

Cough Suppressant

Dosing Cup Included

Alcohol-free

Orange-Flavored Liquid

COMPARE TO ACTIVE INGREDIENT IN DELSYM®

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

12 Hour Cough Relief Carton Image 1
12 Hour Cough Relief Carton Image 2
12 HOUR COUGH RELIEF 
dextromethorphan polistirex suspension
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55312-384
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLISTIREX 
HIGH FRUCTOSE CORN SYRUP 
GLYCERIN 
METHYLPARABEN 
POLYSORBATE 80 
POVIDONES 
PROPYLPARABEN 
WATER 
SODIUM METABISULFITE 
SODIUM POLYSTYRENE SULFONATE 
SUCROSE 
TARTARIC ACID 
TRAGACANTH 
TRIACETIN 
XANTHAN GUM 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-384-211 in 1 CARTON
189 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113509/14/2012
Labeler - Western Family Foods Inc (192166072)

Revised: 11/2012
Document Id: 5daa0727-02ba-4f8e-86a9-2286716648bc
Set id: 5daa0727-02ba-4f8e-86a9-2286716648bc
Version: 1
Effective Time: 20121108
 
Western Family Foods Inc