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RelCof IR

Dosage form: tablet
Ingredients: GUAIFENESIN 380mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: BUREL PHARMACEUTICALS, INC
NDC Code: 35573-323

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.

Drug Facts

Active ingredientsPurpose
 Guaifenesin 380 mgExpectorant
 Phenylephrine HCl 10 mgNasal Decongestant

Uses Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

WARNINGS Do not exceed the recommended dosage.

Do not use this product: 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 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:
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Stop use and ask doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistant headache. A persistant cough may be a sign of a serious  condition
  • New symptoms occur

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.

Directions: Do not exeed recommended dosage.
Adult and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.

Children 6 to under 12 years of age:

1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours.
Children inder 6 years of age:Consult a physician.

Relcof IR Tablets are white, oval-shaped, scored tablets, debossed "BL" bisect "323" on one side, and plain on the other side.

Inactive Ingredients: ´╗┐colloidal silicon dioxide, croscrmellose sodium, hypromellose, maltodextrin, povidone, silicified microcrystalline cellulose, and stearic acid.

Other Information: Store at controlled room temperature between 15° - 30°C (59°-86°F).

Questions? Comments?

To report a serious adverse event or obtain product information, contact 1-601-706-9819

Manufactured For: Burel Pharmaceuticals, Inc. • 199 Interstate Dr. • Richland, MS 39218

35573-323-60

RelCof™
IR

EXPECTORANT•NASAL DECONGESTANT

Each tablet contains:

Guaifenesin.......................................380 mg
Phenylephrine HCl...............................10 mg

Burel Pharmaceuticals

Tamper evident by foil seal uder cap.
Do not use if foil seal is broken or missing.

Net Content: 60 Tablets

RELCOF IR 
guaifenesin, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35573-323
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN380 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MALTODEXTRIN 
POVIDONE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint CodeBL;323
Contains    
Packaging
#Item CodePackage Description
1NDC:35573-323-6060 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/22/2016
Labeler - BUREL PHARMACEUTICALS, INC (002152814)

Revised: 12/2017
 
BUREL PHARMACEUTICALS, INC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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