RABOFEN DM- guaifenesin and dextromethorphan hydrobromide solution 
REMEDYREPACK 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.

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Rabofen™ DM

Drug Facts

Active ingredients (in each 2 TSP (10 mL))Purposes
Dextromethorphan HBr, USP 20 mgCough suppressant
Guaifenesin, USP 200 mgExpectorant

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 over2 TSP every 4 hours
children under 12 yearsdo 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

DRUG: Rabofen DM

GENERIC: Guaifenesin and Dextromethorphan Hydrobromide

DOSAGE: SOLUTION

ADMINSTRATION: ORAL

NDC: 61786-964-45

COLOR: red

FLAVOR: CHERRY

PACKAGING: 118 mL in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • Dextromethorphan Hydrobromide 10mg in 5mL
  • Guaifenesin 100mg in 5mL

INACTIVE INGREDIENT(S):

  • Corn Syrup
  • FD&C Red no. 40
  • PRUNUS SEROTINA BARK
  • WATER
  • MENTHOL, UNSPECIFIED FORM
  • ANHYDROUS CITRIC ACID
  • Saccharin Sodium
  • Glycerin
  • Sodium Benzoate

Remedy_Label

RABOFEN DM 
guaifenesin and dextromethorphan hydrobromide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61786-964(NDC:0904-0053)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorred (Reddish-Pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-964-45118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/31/201603/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/31/201603/16/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 11/2018
Document Id: 7bd73bba-db40-a3ef-e053-2991aa0a5f88
Set id: 809360e1-41bc-43b2-98e8-d47481812753
Version: 2
Effective Time: 20181129
 
REMEDYREPACK INC.