GUIAFENESIN - guaifenesin tablet 
Sunrise Pharmaceutical Inc

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.

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ACTIVE INGREDIENT

Guaifenesin  400 mg.

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)

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.

IF PREGNANT OR BREAST FEEDING

Ask a health professional before use.

DOSAGE AND ADMINISTRATION

Dosage and Administration text

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

0c8dbd91-figure-01
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 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorImprint Code TCL;272
Contains    
Packaging
#Item CodePackage Description
1NDC:11534-164-01100 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)

Revised: 09/2011
Document Id: 0c8dbd91-6b0e-41eb-a51e-82b3871f003a
Set id: 5e3875ba-d34c-48b2-93ec-baa27f6a37a2
Version: 1
Effective Time: 20110906
 
Sunrise Pharmaceutical Inc