Guaifenesin by Chalkboard Health / Aurohealth LLC / Aurobindo Pharma Limited Drug Facts

Drug Details [pdf]

GUAIFENESIN - guaifenesin tablet, extended release
Chalkboard Health

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Drug Facts

Active Ingredients

(in each extended-release tablet)
Guaifenesin USP 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

store between 20° to 25°C (68° to 77°F)
Tamper evident: Do not use if carton is open or if seal on blister is broken or missing

Inactive ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize)

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number.

Distributed By:
ChalkBoard Health, Inc.
Princeton, NJ 08540
getfluenthealth.com

Made in India

Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton (20 (1 x 20) Tablets)

NDC: 79395-001-96

Fluent™

Mucus
Relief

Guaifenesin
Extended-Release
Tablets 600 mg

EXPECTORANT

Relieves Chest Congestion
Thins And Loosens Mucus
Lasts up to 12 Hours

20 Extended-Release Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablet Label)

GUAIFENESIN
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79395-001
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
POVIDONE K90 (UNII: RDH86HJV5Z)
POVIDONE K25 (UNII: K0KQV10C35)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (white to off-white)	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	L;68
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 79395-001-96	1 in 1 CARTON	08/01/2020	04/30/2022
1		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
ANDA	ANDA210453	08/01/2020	04/30/2022

Labeler - Chalkboard Health (117569507)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
APL HEALTHCARE LIMITED		650918514	ANALYSIS(79395-001) , MANUFACTURE(79395-001)

Revised: 10/2022

Document Id: f361acca-c895-4f6c-a10b-805cf5f037ef

Set id: 9031f57b-fe88-4dec-87dd-86ba39a8ef11

Version: 4

Effective Time: 20221029