ROBAFEN COUGH FORMULA- guaifenesin syrup

ROBAFEN COUGH FORMULA by

Drug Labeling and Warnings

ROBAFEN COUGH FORMULA by is a Otc medication manufactured, distributed, or labeled by Aidarex Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• each teaspoonful (5 mL) contains: sodium 3 mg
• store at room temperature 15°-30°C (59°-86°F)

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ROBAFEN COUGH FORMULA 
guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53217-024(NDC:0904-0061)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN (Reddish-Brown)	Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53217-024-01	118 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/15/2012

Labeler - Aidarex Pharmaceuticals LLC (801503249)