Guaifenesin Extended Release (Guaifenesin) Tablet, Extended Release [Perrigo New York Inc] -

GUAIFENESIN EXTENDED RELEASE (GUAIFENESIN) TABLET, EXTENDED RELEASE [PERRIGO NEW YORK INC]
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NDC	45802-325-30, 45802-325-66
Set ID	ab2cbee0-531f-48ef-b900-ac1388ba7de9
Category	HUMAN OTC DRUG LABEL
Packager	Padagis Israel Pharmaceuticals Ltd
Generic Name
Product Class
Product Number
Application Number	ANDA091009

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Active ingredient (in each extended-release tablet)

Guaifenesin 1200 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

Do not use

•

for children under 12 years of age

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 (1-800-222-1222).
Directions

•

do not crush, chew, or break tablet

•

take with a full glass of water

•

this product can be administered without regard for the timing of meals

•

adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.

•

children under 12 years of age: do not use
Other information

•

store between 20°-25°C (68°-77°F)

•

do not use if printed foil under cap is broken or missing
Inactive ingredients

colloidal silicon dioxide, copovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate Type A, stearic acid
Questions or comments?

1-800-719-9260
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Compare to Maximum Strength Mucinex® active ingredient

Maximum Strength

Guaifenesin Extended-Release Tablets, 1200 mg

Expectorant

12 Hour

Relieves Chest Congestion

Thins and Loosens Mucus

Actual Size

14 Extended-Release Tablets

INGREDIENTS AND APPEARANCE

GUAIFENESIN EXTENDED RELEASE
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-325
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	OVAL (Biconvex)	Size	22mm
Flavor		Imprint Code	Watson;1200
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45802-325-30	1 in 1 CARTON	01/25/2016	07/02/2018
1		28 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:45802-325-66	1 in 1 CARTON	03/16/2016	12/31/2021
2		14 in 1 BOTTLE; Type 0: Not a Combination Product