Skip to Content

Robafen AC

Medically reviewed on January 19, 2018

Dosage form: syrup
Ingredients: Guaifenesin 100mg in 5mL, Codeine Phosphate 10mg in 5mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-6479

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.

Robafen AC™ Oral Solution

Drug Facts

Active ingredient (in each TSP (5 mL))Purposes
Codeine Phosphate, USP 10 mgCough suppressant
Guaifenesin USP 100 mgExpectorant

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
AgeDose
adults and children 12 years and over2 TSP
children 6 to under 12 years of age1 TSP
children under 6 years of agedo 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

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

ROBAFEN AC 
guaifenesin and codeine phosphate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6479
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin100 mg  in 5 mL
Codeine Phosphate (CODEINE ANHYDROUS) Codeine Phosphate10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
CHERRY 
Caramel 
Anhydrous Citric Acid 
EDETATE DISODIUM 
FD&C Red no. 40 
Glycerin 
WATER 
Saccharin Sodium 
Sodium Benzoate 
SORBITOL 
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6479-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/14/2017
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
Bio-Pharm, Inc.801652546MANUFACTURE(0904-6479), ANALYSIS(0904-6479), PACK(0904-6479), LABEL(0904-6479)

 
Major Pharmaceuticals

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide