Tussin 12 hr suspension, extended release

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 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 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, 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

Ingredients and appearance - Product information

Tussin 12 hr suspension, extended release- Dextromethorphan polistirex

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 69842-751
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
D&c red no. 30 ( UNII: 2S42T2808B)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Methylparaben ( UNII: A2I8C7HI9T)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Polyvinyl acetate ( UNII: 32K497ZK2U)
Povidone, unspecified ( 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)
Glycerin ( UNII: PDC6A3C0OX)

Product Characteristics

Color ORANGE Flavor ORANGE

Marketing Information

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

Labeler - CVS Pharmacy( 062312574)

Package/label principal display panel

Compare to the active ingredient in Robitussin ®Extended-Release 12 Hour Cough Relief

Tussin 12 HR

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION

Cough Suppressant

Alcohol free

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

12 HOUR COUGH RELIEF

Orange-Flavored Liquid

Dosing cup included

3 FL OZ (89 mL)