Cough dm suspension, extended release

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 Parkinsons 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 25C (68 to 77F)
  • 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 1-800-719-9260

You may also report side effects to this phone number.

Ingredients and appearance - Product information

Cough dm suspension, extended release- Dextromethorphan polistirex

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11822-0494
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 30 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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)
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 PURPLE Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091135 USA

Labeler - Rite Aid Corporation( 014578892)

Package/label principal display panel

Compare to the active ingredient of Delsym®

cough DM

dextromethorphan polistirex extended-release oral suspension

cough suppressant

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

day or night

12 HOUR cough relief

ALCOHOL-FREE

grape-flavored liquid

dosing cup included

3 FL OZ (89 mL)