Rabofen Dm (Guaifenesin And Dextromethorphan Hydrobromide) Solution [Major Pharmaceuticals] -

RABOFEN DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [MAJOR PHARMACEUTICALS]
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NDC	0904-0053-00, 0904-0053-09, 0904-0053-16
Set ID	5d52a150-6793-469f-bace-596ee91b2045
Category	HUMAN OTC DRUG LABEL
Packager	Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number	PART341

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

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
SPL UNCLASSIFIED SECTION

Distributed by:
MAJOR ® PHARMACEUTICALS
17177 N Laurel Park Drive,
Suite 233, Livonia, MI 48152
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
NDC 0904-0053-00
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)

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

INGREDIENTS AND APPEARANCE

RABOFEN DM
guaifenesin and dextromethorphan hydrobromide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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:0904-0053-00	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2004	01/31/2021
2	NDC:0904-0053-09	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2004	08/31/2020
3	NDC:0904-0053-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2004	10/31/2020