Robafen® CF Cough & cold

Drug Labeling and Warnings

Drug Details [pdf]

ROBAFEN CF COUGH AND COLD- guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride solution 
Major Pharmaceuticals

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.

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Robafen® CF Cough & cold

Drug Facts

Active ingredients (in each TSP (5 mL))	Purpose
Dextromethorphan HBr USP 10mg	Cough suppressant
Guaifenesin USP 100mg	Expectorant
Phenylephrine HCL USP 5 mg	Nasal Decongestant

Uses

• Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• Temporarily relieves these symptoms occurring with a cold:
  • nasal congestion.
  • cough due to minor throat and bronchial irritation.

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinsons disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• Heart disease
• Diabetes
• High blood pressure
• Thyroid disease
• Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• Cough that occurs with too much phlegm (mucus)
• Trouble urinating due to an enlarged prostate gland

When using this product

• do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless.
• symptoms do not get better within 7 days or are accompanied by fever.
• 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 reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

• Do not exceed 6 doses in any 24 hour period

• age:

  dose

• Adults and children 12 years and over:

  2 TSP (teaspoonful) every 4 hours

• children under 12 years:

  do not use

Other Information

• Dosage cup provided.
• Each TSP (5ml) contains: sodium 4mg.
• Store at 20 - 25 ˚C(68-77 ˚F).

Inactive Ingredients

citric acid, flavor, glycerin, menthol, propylene glycol, purified water, FD&C Red # 40, sodium benzoate, sodium saccharin, sorbitol.

Questions or Comments?

1-800-616-2471

•   Distributed by: MAJOR® PHARMACEUTICALS
  31778 Enterprise Drive
  Livonia, MI 48150 USA

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

See New
Dosing Information

NDC: 0904-6309-20

MAJOR®

ROBAFEN®

CF
COUGH
& COLD

COUGH SUPPRESSANT (Dextromethorphan HBr)
EXPECTORANT (Guaifenesin)
NASAL DECONGESTANT (Phenylephrine HCL)

Relieves:

• Cough
• Stuffy Nose
• Chest Congestion

Non-Drowsy

COMPARE TO the active
ingredients of ROBITUSSIN® CF*

FOR AGES 12 AND OVER

4 FL OZ (118 mL)

ROBAFEN CF COUGH AND COLD 
guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6309
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
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Cherry (UNII: BUC5I9595W)
Sorbitol (UNII: 506T60A25R)
FD&C Red NO. 40 (UNII: WZB9127XOA)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6309-20	1 in 1 CARTON	03/05/2013	04/29/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/05/2013	04/29/2019

Labeler - Major Pharmaceuticals (191427277)

Revised: 8/2018

Document Id: f9196370-2776-452e-bc5d-41bb4f6fcc7f

34390-5

Set id: 22bc53c2-e4b4-4821-b80d-8a783d77836a

Version: 2

Effective Time: 20180806