GUAIFENESIN EXTENDED RELEASE- guaifenesin tablet, extended release

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by SAM'S WEST INC, Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 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 extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
• children under 12 years of age: do not use

Other information

• store between 20-25°C (68-77°F)
• TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.

Inactive ingredients

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE, AR 72716

PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Blister Pack Carton

Compare to Maximum Strength Mucinex®
active ingredient*

NDC: 68196-996-56

Member's Mark™

Maximum Strength

Mucus Relief

Guaifenesin Extended-Release
Tablets, 1200 mg
Expectorant

• Relieves chest congestion
• Thins and loosens mucus

12
HOUR

56
Extended-
Release
Tablets

INGREDIENTS AND APPEARANCE

GUAIFENESIN  EXTENDED RELEASE
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-996
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
hypromellose, unspecified (UNII: 3NXW29V3WO)
magnesium stearate (UNII: 70097M6I30)
silicon dioxide (UNII: ETJ7Z6XBU4)
povidone, unspecified (UNII: FZ989GH94E)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	RH;99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68196-996-56	4 in 1 CARTON	01/12/2022
1		14 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209254	01/12/2022

Labeler - SAM'S WEST INC (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	MANUFACTURE(68196-996)