Kroger Co. Cough DM Drug Facts

Kroger Co. Cough DM Drug Facts

Drug Labeling and Warnings

Drug Details

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COUGH DM- dextromethorphan polistirex suspension, extended release 
Kroger Company

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Kroger Co. 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 a 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, FD&C Blue #1, 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?

call 1-800-632-6900

You may also report side effects to this phone number.

Package/Label Principal Display Panel

COMPARE TO the active ingredient of DELSYM® See top panel

Cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

COUGH SUPPRESSANT

Contains Sodium Metabisulfite, a Sulfite That May Cause Allergic-Type Reactions

Day or Night

Alcohol-Free

Dosing Cup Included

Our Pharmacists Recommend

12 HOUR COUGH RELIEF

Grape Flavored Liquid

3 FL OZ (89 mL)

494-45-cough-dm.jpg
COUGH DM 
dextromethorphan polistirex suspension, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30142-494
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ACETATE (UNII: 32K497ZK2U)  
POVIDONES (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)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 30142-494-211 in 1 CARTON06/28/2018
189 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113506/28/2018
Labeler - Kroger Company (006999528)

Revised: 7/2018
 
Kroger Company


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