Hy-Vee, Inc. Cough DM Drug Facts

Drug Details [pdf]

COUGH DM- dextromethorphan polistirex suspension
HyVee Inc

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Hy-Vee, Inc. Cough DM Drug Facts

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

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

COMPARE TO the Active Ingredient of Delsym®

Cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

Cough Suppressant

12 Hour Cough Relief

Dosing Cup Included

Day or Night

Alcohol Free

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

Orange-Flavored Liquid

Alcohol-free

3 FL OZ (89 mL)

COUGH DM
dextromethorphan polistirex suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-384
Route of Administration	ORAL

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)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 42507-384-21	1 in 1 CARTON	09/02/2012	07/01/2019
1		89 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 42507-384-28	1 in 1 CARTON	08/05/2013	11/01/2016
2		148 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	09/02/2012	07/01/2019

Labeler - HyVee Inc (006925671)

Revised: 7/2019

Document Id: d85808fc-6200-425c-8b57-c0b6641439b5

Set id: ce7dafc6-1c23-40d2-94d0-2568298fd7ff

Version: 5

Effective Time: 20190719