ROBAFEN COUGH FORMULA- guaifenesin syrup 
Aidarex Pharmaceuticals 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.

----------

ROBAFEN™ COUGH FORMULA

Drug Facts

Active ingredient (in each teaspoonful (5 mL))

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
  • cough occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts 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

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

 adults and children 12 years and over 2 - 4 teaspoons every 4 hours or as directed by a doctor
 children under 12 years do not use

Other information

Inactive ingredients

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

Questions?

Adverse Drug Event Call: (800) 616-2471

Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

PRINCIPAL DISPLAY PANEL

NDC 53217-0024-01
TAMPER-EVIDENT

Robafen
Syrup

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

EXPECTORANT

Each teaspoonful (5 mL) contains:

Guaifenesin
  (Glyceryl Guaiacolate), USP    100 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
31778 Enterprise Drive
Livonia, MI 48150 USA

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

IMAGE LABEL

ROBAFEN COUGH FORMULA 
guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53217-024(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 (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:53217-024-01118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/15/2012
Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 10/2013
Document Id: 0b3cb041-1d4b-486d-937b-95e06b0b9882
Set id: a925e169-a63d-4614-925e-e556daef9ec5
Version: 1
Effective Time: 20131003
 
Aidarex Pharmaceuticals LLC