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 over	2 - 4 TSP every 4 hours
children under 12 years	do 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

DRUG: ROBAFEN COUGH FORMULA

GENERIC: Guaifenesin

DOSAGE: SYRUP

ADMINSTRATION: ORAL

NDC: 61786-963-45

COLOR: brown

FLAVOR: MENTHOL

PACKAGING: 118 mL in 1 BOTTLE

ACTIVE INGREDIENT(S):

Guaifenesin 100mg in 5mL

INACTIVE INGREDIENT(S):

Corn Syrup
FD&C Red no. 40
Menthol, Unspecified Form
Caramel
Water
Glycerin
Sodium Benzoate
Propylene Glycol
Anhydrous Citric Acid
Saccharin Sodium

Remedy_Label

ROBAFEN COUGH FORMULA
guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61786-963(NDC:0904-0061)
Route of Administration	ORAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61786-963-45	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/31/2016

Labeler - REMEDYREPACK INC. (829572556)

Robafen™ Syrup