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ROBAFEN COUGH FORMULA by NuCare Pharmceuticals,Inc.

Medically reviewed on September 14, 2017

Dosage form: syrup
Ingredients: GUAIFENESIN 100mg in 5mL
Labeler: NuCare Pharmceuticals,Inc.
NDC Code: 68071-3020

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.

Robafen™ Syrup

Drug Facts

Active ingredient (in each 2 TSP (10 mL) )

Guaifenesin USP 200 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • a cough 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
  • this product is not intended for use in children under 12 years of age
  • TSP = teaspoonful
adults and children 12 years and over2 - 4 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.

Inactive ingredients

caramel powder, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, propylene glycol, 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 -

ROBAFEN COUGH FORMULA 
guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-3020(NDC:0904-0061)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 
SODIUM BENZOATE 
SACCHARIN SODIUM 
ANHYDROUS CITRIC ACID 
GLYCERIN 
MENTHOL, UNSPECIFIED FORM 
CORN SYRUP 
WATER 
CARAMEL 
FD&C RED NO. 40 
Product Characteristics
Colorbrown (Reddish-Brown) Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68071-3020-4120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/2012
Labeler - NuCare Pharmceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIOperations
NuCare Pharmceuticals,Inc.010632300relabel(68071-3020)

 
NuCare Pharmceuticals,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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