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 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° to 25°C (68° to 77°F)

Inactive ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and 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:
AUROHEALTH LLC.
279 Princeton-Hightstown Road,
East Windsor, NJ 08520

Made in India

Code: AP/DRUGS/04/2016

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Label)

AUROHEALTH

NDC 58602-811-05

MAXIMUM STRENGTH

Guaifenesin
Extended-Release
Tablets 1200 mg
EXPECTORANT

12
HOUR

Relieves Chest Congestion
Thins And Loosens Mucus

14
Extended-Release
Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Carton Label)

AUROHEALTH

NDC 58602-811-05

Compare to the active
Ingredient in Maximum

Strength Mucinex®*

MAXIMUM STRENGTH

Guaifenesin Extended-Release Tablets 1200 mg
EXPECTORANT

Relieves Chest Congestion
Thins And Loosens Mucus

12
HOUR

14

Extended-Release
Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets)

AUROHEALTH

NDC 58602-811-01

Compare to the active
Ingredient in Maximum

Strength Mucinex®*

MAXIMUM STRENGTH

Guaifenesin
Extended-Release Tablets 1200 mg
EXPECTORANT

Relieves Chest Congestion
Thins And Loosens Mucus

14
Extended-Release
Tablets

12 HOUR

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets)

GUAIFENESIN
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58602-811
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)
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	21mm
Flavor		Imprint Code	L;69
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58602-811-05	1 in 1 CARTON	10/21/2019
1		14 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:58602-811-73	1 in 1 CARTON	10/21/2019
2		20 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:58602-811-57	1 in 1 CARTON	10/21/2019
3		28 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:58602-811-12	1 in 1 CARTON	10/21/2019
4		40 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:58602-811-60	1 in 1 CARTON	10/21/2019
5		42 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:58602-811-21	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2019
7	NDC:58602-811-01	1 in 1 CARTON	10/21/2019
7		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC:58602-811-02	2 in 1 CARTON	10/21/2019
8		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC:58602-811-03	3 in 1 CARTON	10/21/2019
9		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC:58602-811-56	4 in 1 CARTON	01/31/2020
10		14 in 1 BLISTER PACK; Type 0: Not a Combination Product
11	NDC:58602-811-64	1 in 1 CARTON	11/26/2020
11		7 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	10/21/2019

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
APL HEALTHCARE LIMITED		650918514	ANALYSIS(58602-811) , MANUFACTURE(58602-811)

Drug Facts

Active ingredient

Purpose

Uses

Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions?

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Carton Label)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (14 (1 x 14) Tablets)