TUSSIN- guaifenesin 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

Drug Facts

Active ingredient (in each 5mL TSP (teaspoon))

Guaifenesin USP 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

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 over2-4 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

caramel powder, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium saccharin

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 INGREDIENT IN
ROBITUSSIN®*

NDC 59741-112-10

ASSURED™

ADULT

Tussin

Guaifenesin Oral
Solution, USP

Expectorant

AGES 12+

  • Alcohol Free
  • Non-Drowsy

Relieves Chest
Congestion & Mucus

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton
TUSSIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59741-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Menthol (UNII: L7T10EIP3A)  
Water (UNII: 059QF0KO0R)  
Corn Syrup (UNII: 9G5L16BK6N)  
Caramel (UNII: T9D99G2B1R)  
FD&C Red no. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorBROWN (Reddish-Brown) Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59741-112-101 in 1 CARTON04/08/201402/29/2016
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/08/201402/29/2016
Labeler - Bio-Pharm, Inc. (801652546)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Pharm, Inc.801652546MANUFACTURE(59741-112) , ANALYSIS(59741-112) , PACK(59741-112) , LABEL(59741-112)

Revised: 8/2018
Document Id: 985ceddb-677c-431a-a14f-8f621a1ca95a
Set id: d629b885-abfd-44ca-980e-c867d4fdbb8e
Version: 2
Effective Time: 20180824
 
Bio-Pharm, Inc.