OTC Medication Information: ROBAFEN COUGH FORMULA

ROBAFEN COUGH FORMULA- guaifenesin syrup
REMEDYREPACK INC.

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.

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg in 5 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL SODIUM BENZOATE SACCHARIN SODIUM ANHYDROUS CITRIC ACID GLYCERIN MENTHOL, UNSPECIFIED FORM CORN SYRUP WATER CARAMEL FD&C RED NO. 40

Product Characteristics Color brown (Reddish-Brown) Score Shape Size Flavor MENTHOL Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:61786-963-45 118 mL in 1 BOTTLE None

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)

Revised: 10/2017 REMEDYREPACK INC.