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Rabofen DM by NuCare Pharmaceuticals,Inc.

Medically reviewed on October 31, 2017

Dosage form: solution
Ingredients: GUAIFENESIN 100mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL
Labeler: NuCare Pharmaceuticals,Inc.
NDC Code: 68071-4143

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 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

PRINCIPAL DISPLAY PANEL -

RABOFEN DM 
guaifenesin and dextromethorphan hydrobromide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4143(NDC:0904-0053)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE 
SACCHARIN SODIUM 
ANHYDROUS CITRIC ACID 
GLYCERIN 
MENTHOL, UNSPECIFIED FORM 
WATER 
CORN SYRUP 
PRUNUS SEROTINA BARK 
FD&C RED NO. 40 
Product Characteristics
Colorred (Reddish-Pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68071-4143-4120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2004
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIOperations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-4143)

 
NuCare Pharmaceuticals,Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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