TUSSIN DM- guaifenesin and dextromethorphan hydrobromide solution 
Bio-Pharm, Inc.

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.

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Tussin DM

Drug Facts

Active ingredients (in each 5mL TSP (teaspoon))Purpose
Dextromethorphan HBr USP 10mgCough suppressant
Guaifenesin USP 100 mg.Expectorant

Uses

  • temporarily quiets cough associated with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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

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

Stop use and ask a doctor if cough lasts for more than 7 days, 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • use only enclosed dosing cup to dose this product
  • do not take more than 6 doses in any 24 hour period
  • this product is not intended for use in children under 12 years of age
adults and children 12 years and over2 TSP every 4 hours or as directed by doctor
children under 12 yearsdo not use

Other information

  • each TSP (5 mL) contains: sodium 3 mg
  • TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, corn syrup, FD&C Red #40, glycerin, menthol, purified water, sodium benzoate, sodium saccharin, wild cherry flavor

Questions or comments?

866-845-1611

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

COMPARE TO ACTIVE INGREDIENTS IN
ROBITUSSIN® DM*

NDC 59741-116-10

ASSURED™

ADULT

Tussin DM

Dextromethorphan HBr USP

- Cough Suppressant

Guaifenesin USP

- Expectorant

AGES 12+

  • Alcohol Free
  • Non-Drowsy

Relieves Cough, Chest
Congestion & Mucus

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton
TUSSIN DM 
guaifenesin and dextromethorphan hydrobromide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59741-116
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate (UNII: OJ245FE5EU)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Glycerin (UNII: PDC6A3C0OX)  
Menthol, unspecified form (UNII: L7T10EIP3A)  
Water (UNII: 059QF0KO0R)  
Corn Syrup (UNII: 9G5L16BK6N)  
Prunus Serotina Bark (UNII: 5D48E975HA)  
FD&C Red no. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorRED (Reddish-Pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59741-116-101 in 1 CARTON01/01/200401/31/2017
1NDC:59741-116-06118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/200401/31/2017
Labeler - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Pharm, Inc.801652546MANUFACTURE(59741-116) , ANALYSIS(59741-116) , PACK(59741-116) , LABEL(59741-116)

Revised: 8/2018
Document Id: b2f084c1-6ad8-46ed-9376-6b379caec3aa
Set id: a817ade4-18bf-4f7f-9b5f-5a1407a909de
Version: 3
Effective Time: 20180824
 
Bio-Pharm, Inc.