Guaifenesin by REMEDYREPACK INC. GUAIFENESIN tablet

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each immediate-release tablet)

Guaifenesin 200 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

• persistent or chronic cough 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 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.

Keep out of reach of children.

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

Directions

• do not exceed 6 doses in 24 hours
• take with a full glass of water

• adults and children 12 years of age and over: 1 to 2 tablets every ; 4 hours
• children 6 to under 12 years of age:

  ½ to 1 tablet every ; 4 hours

• children under 6 years of age: consult a physician

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• use by expiration date on package

Inactive ingredients

FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

Questions or comments?

(800) 616-2471

PRINCIPAL DISPLAY PANEL

DRUG: Guaifenesin

GENERIC: Guaifenesin

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-511-02

COLOR: pink

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: 44;588

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• GUAIFENESIN 200mg in 1

INACTIVE INGREDIENT(S):

• FD&C RED NO. 40
• MAGNESIUM STEARATE
• STEARIC ACID
• POVIDONE
• CELLULOSE, MICROCRYSTALLINE
• MALTODEXTRIN
• SILICON DIOXIDE

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49349-511(NDC:0904-5154)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	pink (dark)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;588
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49349-511-02	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/12/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/12/2010

Labeler - REMEDYREPACK INC. (829572556)