HEALTHY ACCENTS TUSSIN COUGH ADULT- dextromethorphan hydrobromide liquid 
DZA Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

DZA Brands, LLC Adult Tussin Cough Drug Facts

Active ingredient (in each 5 mL tsp)

Dextromethorphan HBr, USP 15 mg

Purpose

Cough suppressant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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.

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign 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.

Directions

  • do not take more than 4 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
agedose
children under 12 yearsdo not use

adults and children

12 years and over

2 teaspoons

every 6 to 8 hours

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

1-866-322-2439

Principal Display Panel

Adult

Tussin

Cough

Long-Acting

Cough Suppressant

(Dextromethorphan HBr)

Relieves Cough up to 8 hours

Non-Drowsy

For ages 12 & over

Compare to Robitussin® Cough Long-Acting active ingredient

Alcohol 1.4%

Adult Tussin Cough Carton Image 1

Adult Tussin Cough Carton Image 1

Adult Tussin Cough Carton Image 2

Adult Tussin Cough Carton Image 2

HEALTHY ACCENTS TUSSIN COUGH  ADULT
dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55316-300
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
MENTHOL 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-300-261 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/22/2008
Labeler - DZA Brands LLC (090322194)

Revised: 7/2009
Document Id: 5e5fa582-8a98-4fdc-899f-562b79a33cec
Set id: 5e5fa582-8a98-4fdc-899f-562b79a33cec
Version: 1
Effective Time: 20090701
 
DZA Brands LLC