TUSSIN DM- dextromethorphan hydrobromide and guaifenesin liquid 
davAgen Pharmaceutical, 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.

----------

Tussin DM

Active ingredients (in each 5 mL tsp):Purpose
Dextromethorphan HBr, USP 10 mgCough suppressant
Guaifenesin, USP 100 mgExpectorant

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) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Do not exceed recommended dose

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.

Other information

Each tsp contains: sodium 6.5 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate.

Dosage cup provided.

Inactive ingredients

citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Directions

do not take more than 6 doses in any 24-hour period

agedose
adults and children 12 years and over10 mL (2 tsp) every 4 hours
children under 12 yearsdo not use

Manufactured by:
davAgen
Pharmaceutical LLC
Somerset, NJ 08873

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

davAgen
pharmaceutical

NDC 76140-106-08

Adults & Children Ages 12 & Older

Tussin DM
Cough &
Chest Congestion

Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin

For Relief of:

8 FL OZ (237 mL)

Principal Display Panel - 237 mL Bottle Label
TUSSIN DM 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76140-106
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
Sodium Benzoate 
Citric Acid Monohydrate 
Sorbitol 
Saccharin Sodium 
Sucralose 
FD&C Red No. 40 
Propylene Glycol 
Glycerin 
Sodium Citrate 
Menthol 
Water 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorTROPICAL FRUIT PUNCH, ORANGE, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76140-106-081 in 1 CARTON
1236 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/10/2013
Labeler - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIBusiness Operations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(76140-106), PACK(76140-106), LABEL(76140-106), ANALYSIS(76140-106)

Revised: 12/2013
Document Id: 0e6409bc-15a7-4d73-b4de-3952e31cb7f3
Set id: 3a101213-5d6a-4f20-8f67-2dcda375d73b
Version: 1
Effective Time: 20131230
 
davAgen Pharmaceutical, LLC