Your browser does not support JavaScript! MUCAPHED (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [EDWARDS PHARMACEUTICALS, INC.]
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RxNorm Names

MUCAPHED (guaifenesin and phenylephrine hydrochloride) tablet, coated
[EDWARDS PHARMACEUTICALS, INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Drug Facts

ACTIVE INGREDIENTS
(each tablet contains)
PURPOSE
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal Decongestant

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis) and helps loosen phlegm (mucus) and thin bronchial secretions to:

  • drain bronchial tubes
  • make coughs more productive
  • nasal stuffiness
  • reduces swelling of nasal passages
  • helps decongest sinus openings and passages

Warnings

  • Do not exceed 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 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that is accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms are accompanied by a persistent cough for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache
  • if symptoms do not improve within 7 days or accompanied by a fever — 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 immediately.

Directions

Do not exceed recommended dosage.

Adults 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:½ tablet every 4 hours, not to exceed 3 tablets in 24 hours
Children under 6 years of age:Consult a doctor.

Other information

  • store between 15°-30° C (59°-86° F)
  • Caution: do not use if imprinted seal under cap is broken or missing

Inactive ingredients

croscarmellose sodium, hypromellose, lactose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium Iauryl sulfate, stearic acid, titanium dioxide, and triacetin

Questions? Comments?

1-800-543-9560

Distributed by:
Edwards Pharmaceuticals, Inc.
Ripley, MS 38663

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

E

NDC 00485-0250-01

MucaphEd

EXPECTORANT
NASAL DECONGESTANT

Each tablet contains:
Guaifenesin 400 mg
Phenylephrine HCl 10 mg

100 Tablets

Distributed by:
Edwards Pharmaceuticals, Inc.
Ripley, MS 38663

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
MUCAPHED 
guaifenesin and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0485-0250
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM SILICATE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POVIDONES 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize18mm
FlavorImprint Code PH;0A3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0485-0250-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/11/2012
Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)

Revised: 3/2013
 
EDWARDS PHARMACEUTICALS, INC.

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