Guiafenesin

Dosage form: tablet
Ingredients: GUAIFENESIN 400mg
Labeler: Sunrise Pharmaceutical Inc
NDC Code: 11534-164

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.

Guaifenesin  400 mg Expectorant

OTC - ACTIVE INGREDIENT

Guaifenesin  400 mg.

OTC - PURPOSE

Expectorant.

INDICATIONS AND USAGE

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive.

WARNINGS

Ask a doctor before use if you have

Cough that lasts or chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Cough accompanied by too much phlegm (mucus)

OTC - STOP USE  AND ASK A DOCTOR IF

Cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.

OTC – IF PREGNANT OR BREAST FEEDING

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

Take with a glass of water

Adults and children 12 years and over1 tablet every 4 hour. Max 6 doses
Children 6 to under 12 yearsDo not use
Children under 6 yearsDo not use

OTHER INFORMATION

Store at 15(-30(C(59(-86(F)

INACTIVE INGREDIENT

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
GUIAFENESIN 
guiafenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-164
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
MALTODEXTRIN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorImprint CodeTCL;272
Contains    
Packaging
#Item CodePackage Description
1NDC:11534-164-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/08/2005
Labeler - Sunrise Pharmaceutical Inc (168522378)
Registrant - Sunrise Pharmaceutical Inc (168522378)

Revised: 07/2013
 
Sunrise Pharmaceutical Inc

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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