RABOFEN DM- guaifenesin and dextromethorphan hydrobromide solution
Preferred Pharmaceuticals 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.

----------

Rabofen™ DM

Drug Facts

Active ingredients (in each 2 TSP (10 mL))	Purposes
Dextromethorphan HBr, USP 20 mg	Cough suppressant
Guaifenesin, USP 200 mg	Expectorant

Uses

•: temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
•: helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's 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

•: cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
•: cough that 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
•: use enclosed dosing cup only. Do not use any other device.
•: this adult product is not intended for use in children under 12 years of age
•: TSP=teaspoonful

adults and children 12 years and over	2 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

TAMPER-EVIDENT

Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing

Inactive ingredients

artificial cherry flavor, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, 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

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 68788-0841-1
TAMPER-EVIDENT

MAJOR ®
PHARMACEUTICALS

ROBAFEN™DM

cough formula
Cough Suppressant
Expectorant

*Compare to active ingredients of
Robitussin ®Cough+Chest Congestion DM

Dextromethorphan HBr, USP 20 mg and
Guaifenesin, USP 200 mg per 10 mL

•: Alcohol free
•: Non-narcotic

4 FL. OZ. (118 mL)

Relabeled By: Preferred Pharmaceuticals Inc.

RABOFEN DM
guaifenesin and dextromethorphan hydrobromide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-0841(NDC:0904-0053)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
Sodium Benzoate (UNII: OJ245FE5EU)
Saccharin Sodium (UNII: SB8ZUX40TY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
Glycerin (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
Corn Syrup (UNII: 9G5L16BK6N)
PRUNUS SEROTINA BARK (UNII: 5D48E975HA)
FD&C Red no. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	RED (Reddish-Pink)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68788-0841-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2018	09/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/15/2018	09/08/2020

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-0841)

Revised: 9/2020

Document Id: 0ccf414c-a6e1-44ab-9f5d-75ddaa324089

Set id: 88f0dd33-06ba-406f-b7b9-9b71fe69673f

Version: 3

Effective Time: 20200908

Preferred Pharmaceuticals Inc.