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Mucus Relief D Immediate Release

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Chain Drug Consortium
NDC Code: 68016-182

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 ingredient

Guaifenesin 400 mg
Phenylephrine HCl 10 mg

Purpose

Expectorant
Nasal decongestant

Uses

helps loosen phlegm (mucus) and helps thin bronchial secretions to make coughs more productive temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

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

heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland■ cough accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

When using this product

■ do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless
cough lasts for more than 7 days, recurs, 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 Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older: Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under 12 years of age: do not use

Other Information

store at 25° C (77° F) excursions between 15°-30° C (59°-86° F)do not use if imprinted safety seal under cap is broken or missing You may report side effects to 1-888-952-0050

Inactive Ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Package/Label Principal Display Panel
MUCUS RELIEF D  IMMEDIATE RELEASE
guaifenesin and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-182
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
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
SILICON DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize17mm
FlavorImprint CodeAZ354
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-182-5050 TABLET in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/29/2014
Labeler - Chain Drug Consortium (101668460)
Registrant - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
A&Z Pharmaceutical, Inc.926820705LABEL(68016-182), MANUFACTURE(68016-182), PACK(68016-182), RELABEL(68016-182), REPACK(68016-182)

Revised: 12/2014
 
Chain Drug Consortium

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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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