ROBAFEN COUGH FORMULA- guaifenesin syrup 
Major Pharmaceuticals

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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Robafen™ Syrup

Drug Facts

Active ingredient (in each 2 TSP (10 mL) )

Guaifenesin USP 200 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 persistent or 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 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • 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
  • TSP = teaspoonful
adults and children 12 years and over2 - 4 TSP every 4 hours
children under 12 yearsdo not use

Other information

  • each TSP (5 mL) contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F). Do not refrigerate.

Inactive ingredients

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

Questions or comments?

(800) 616-2471

Distributed by
MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 0904-0061-16
TAMPER-EVIDENT

Robafen™
Syrup

(brand of Guaifenesin syrup USP
100 mg per 5 mL)

EXPECTORANT

Each 2 teaspoonful (10 mL) contains:
Guaifenesin
(Glyceryl Guaiacolate), USP
200 mg

TAMPER-EVIDENT: Do not use this product
if inner foil seal over the mouth of the
bottle is cut, torn, broken or missing.

For Dispensing Purpose Only

Distributed by
MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152

NET: 1 Pint (473 mL)

MAJOR®
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
ROBAFEN COUGH FORMULA 
guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-0061
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)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
CORN SYRUP (UNII: 9G5L16BK6N)  
WATER (UNII: 059QF0KO0R)  
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:0904-0061-00118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/201204/30/2020
2NDC:0904-0061-09237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/201212/31/2016
3NDC:0904-0061-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/201209/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/201209/30/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 9/2019
Document Id: 93c5eb05-cf18-4dda-e053-2a95a90a874f
Set id: 272a2819-9713-4e33-a14e-8be6f8bfebf8
Version: 5
Effective Time: 20190930
 
Major Pharmaceuticals