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 mg Cough suppressant
Guaifenesin, USP 100 mg Expectorant


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.


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


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

age dose
adults and children 12 years and over 10 mL (2 tsp) every 4 hours
children under 12 years do not use

Manufactured by:
Pharmaceutical LLC
Somerset, NJ 08873



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
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76140-106
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Benzoate (UNII: OJ245FE5EU)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Sorbitol (UNII: 506T60A25R)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sucralose (UNII: 96K6UQ3ZD4)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Menthol (UNII: L7T10EIP3A)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Color RED Score     
Shape Size
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76140-106-08 1 in 1 CARTON
1 236 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 04/10/2013
Labeler - davAgen Pharmaceutical, LLC (967545935)
Name Address ID/FEI Business Operations
davAgen Pharmaceutical, LLC 967545935 MANUFACTURE(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