DG HEALTH COUGH DM- dextromethorphan polistirex suspension

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide
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

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?

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Compare to the active ingredient of Delsym®

Day or Night

Cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

Cough Suppressant

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

Alcohol free

Gluten free

Dosing cup included

12 HOUR COUGH RELIEF

Orange Flavored Liquid

3 FL OZ (89 mL)

INGREDIENTS AND APPEARANCE

DG HEALTH COUGH DM
dextromethorphan polistirex suspension

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
POLISTIREX (UNII: 5H9W9GTW27)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ACETATE (UNII: 32K497ZK2U)
POVIDONE (UNII: FZ989GH94E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)
SUCROSE (UNII: C151H8M554)
TARTARIC ACID (UNII: W4888I119H)
TRAGACANTH (UNII: 2944357O2O)
TRIACETIN (UNII: XHX3C3X673)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 55910-384-21	1 in 1 CARTON	07/02/2013
1		89 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA091135	07/02/2013

Labeler - Dolgencorp, LLC (068331990)

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