Your browser does not support JavaScript! HEALTHY ACCENTS TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DZA BRANDS LLC]
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HEALTHY ACCENTS TUSSIN DM (dextromethorphan hydrobromide, guaifenesin) liquid
[DZA Brands LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient (in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

Cough suppressant

Expectorant

Uses

•
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
•
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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, chronic bronchitis or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, comes back, or is accompanied by 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. (1-800-222-1222)

Directions

•
do not take more than 6 doses in any 24-hour period
•
use only with enclosed measuring cup. Do not use any other device.
•
this adult product is not intended for use in children under 12 years of age

age

dose

adults and children

12 years and over

2 teaspoons (tsp) every 4 hours

children under 12 years

do not use

Other information

•
each teaspoon contains: sodium 3 mg
•
store at 20°-25°C (68°-77°F)

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Questions or comments?

1-866-322-2439

Principal Display Panel

adult tussin DM

cough & chest congestion

cough suppressant (dextromethorphan HBr)

expectorant (guaifenesin)

non-drowsy

for ages 12 & over

Compare to Robitussin® Cough + Chest Congestion DM active ingredients

alcohol free

Tussin DM Carton
HEALTHY ACCENTS TUSSIN DM 
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-359
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE 
SODIUM BENZOATE 
MENTHOL 
SUCRALOSE 
Product Characteristics
ColorRED (Orange-Red) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55316-359-261 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:55316-359-341 in 1 CARTON
2237 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: 11/2012
Document Id: 60ebc845-460c-49f4-ac7a-b53c015b52be
Set id: 682bd315-8953-436b-afc0-09509a7df8e8
Version: 2
Effective Time: 20121107
 
DZA Brands LLC

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