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 REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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

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, 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

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

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

Labeler - REMEDYREPACK INC. (829572556)