ROBAFEN DM PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin liquid

ROBAFEN DM PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM by

Drug Labeling and Warnings

ROBAFEN DM PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg

Purposes

Cough suppressant
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 occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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 reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• do not take more than 6 doses (12 tsp) in any 24-hour period
• measure only with dosing cup provided
• keep dosing cup with product
• mL = milliliter
• this adult product is not intended for use in children under 12 years of age

• Age: Dose
• adults and children12 years and over: 10 mL; every 4 hours
• children under 12 years: do not use

Other information

• each 10 mL contains: sodium 6 mg
• store at 20-25°C (68-77°F). Do not refrigerate
• alcohol-free

Inactive ingredients

acesulfame potassium, anhydrous citric acid, flavors, glycerin, hydroxyethyl cellulose, menthol, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions or comments

1-800-616-2471

Distributed by: MAJOR®

PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
Rev. 10/19 M-165 Re-order No. 701197

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

MAJOR®

NDC: 0904-7013-20

Compare to the
active ingredients in
Adult Robitussin® Peak Cold
Sugar-Free & Dye-Free
Cough + Chest Congestion DM*

Adult
Robafen™ DM
Peak Cold

Sugar-Free Cough +
Chest Congestion
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Cough Suppressant/Expectorant

20 mg/200 mg

• Relieves Cough, Mucus
• Specially formulated for diabetics
• For ages 12 and over
• Dye-Free
• Non-Drowsy
• Cherry Flavor

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

ROBAFEN DM PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CHERRY (UNII: BUC5I9595W)
VANILLA (UNII: Q74T35078H)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)
LEVOMENTHOL (UNII: BZ1R15MTK7)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	YELLOW (A clear colorless to slightly yellow)	Score
Shape		Size
Flavor	CHERRY, VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7013-20	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/06/2019

Labeler - Major Pharmaceuticals (191427277)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(0904-7013)