Guaifenesin Tablet, Extended Release [Ohm Laboratories Inc] -

GUAIFENESIN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]
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NDC	51660-070-21, 51660-070-41
Set ID	1cc8add2-55d9-4215-8f7b-07a2a9f45673
Category	HUMAN OTC DRUG LABEL
Packager	OHM LABORATORIES INC
Generic Name
Product Class
Product Number
Application Number	NDA021282

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each extended-release tablet)

Guaifenesin 600 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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.

•

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

•

Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.

•

store between 20-25°C (68-77°F)
Inactive ingredients

carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF
Questions?

(1-800-406-7984)

You may also report side effects to this phone number.
SPL UNCLASSIFIED SECTION

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
NDC 51660-070-41

†Compare To
the active ingredient of
Mucinex®

ohm®

Guaifenesin
Extended-Release Tablets
600 mg
Expectorant

12 Hour
- Relieves Chest Congestion
- Thins and Loosens Mucus
- Immediate and Extended Release
40 Extended-Release Tablets

INGREDIENTS AND APPEARANCE

GUAIFENESIN
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-070
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	600 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	Mxeunic;600
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51660-070-21	1 in 1 CARTON	02/08/2018
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:51660-070-41	2 in 1 CARTON	02/08/2018
2		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021282	01/08/2018

Labeler - OHM LABORATORIES INC (184769029)

Name	Address	ID/FEI	Business Operations
Establishment
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD		230780363	MANUFACTURE(51660-070)

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Medic

GUAIFENESIN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC]

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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