Guiafenesin by Sunrise Pharmaceutical Inc GUIAFENESIN tablet

Guiafenesin by

Drug Labeling and Warnings

Guiafenesin by is a Otc medication manufactured, distributed, or labeled by Sunrise Pharmaceutical Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 over: 1 tablet every 4 hour. Max 6 doses
• Children 6 to under 12 years: Do not use
• Children under 6 years: Do 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

INGREDIENTS AND APPEARANCE

GUIAFENESIN 
guiafenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11534-164
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	TCL;272
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11534-164-01	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/08/2005

Labeler - Sunrise Pharmaceutical Inc (168522378)

Registrant - Sunrise Pharmaceutical Inc (168522378)