ROBAFEN AC- guaifenesin and codeine phosphate syrup

Robafen AC by

Drug Labeling and Warnings

Robafen AC by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each TSP (5 mL))	Purposes
Codeine Phosphate, USP 10 mg	Cough suppressant
Guaifenesin USP 100 mg	Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
• helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Warnings

Do not use

• in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.
• In children following a tonsillectomy and/or adenoidectomy as this could cause severe respiratory distress.

Ask a doctor before use if you have

• a cough with too much phlegm (mucus)
• a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Stop use and ask a doctor if

• cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
• may cause or aggravate constipation

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

• Use of codeine-containing preparation is not recommended for children under 2 years of age

Directions

• take every 4 hours
• do not exceed 6 doses in 24 hours
• giving a higher dose than recommended by a doctor can result in serious side effects for a child. Do not exceed recommended dosage.
• not intended for use in children under 6 years of age
• TSP = teaspoonful

Age	Dose
adults and children 12 years and over	2 TSP
children 6 to under 12 years of age	1 TSP
children under 6 years of age	do not use

Other information

• each (5 mL) teaspoon contains : 4 mg sodium
• Tamper evident: Do not use this product if inner foil seal over the mouth of the bottle is torn, broken or missing.
• Keep container closed and store away from heat. DO NOT REFRIGERATE.
• Store at room temperature 20°-25°C (68°-77°F)
• Dispense in a tight, light-resistant container as defined in the USP.

Inactive ingredients

alcohol 3.5% v/v, artificial cherry flavor, caramel, citric acid, disodium EDTA, FD&C red # 40, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Questions or comments?

1-800-616-2471

SPL UNCLASSIFIED SECTION

Manufactured by:
Bio-Pharm, Inc. Levittown, PA 19057
Distributed by: MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 0904-6479-16

Robafen AC™
Oral Solution CV

(GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION USP)
ANTITUSSIVE EXPECTORANT
SUGAR FREE

Under Federal law Robafen AC is
available without a prescription.
Certain State laws may differ.

BULK CONTAINER - NOT FOR HOUSEHOLD USE.

TAMPER-EVIDENT
DO NOT REFRIGERATE

Manufactured by:
Bio-Pharm, Inc. Levittown, PA 19057
Distributed by: MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152
35-8045-16
REV 08/17 M-64

ONE PINT (473 mL)

MAJOR ®
PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

ROBAFEN AC 
guaifenesin and codeine phosphate syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6479
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CHERRY (UNII: BUC5I9595W)
CARAMEL (UNII: T9D99G2B1R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6479-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2017	10/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/14/2017	10/31/2020

Labeler - Major Pharmaceuticals (191427277)