GUAIFENESIN tablet, extended release

Drug Labeling and Warnings

Drug Details [pdf]

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° 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)

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO ARHA0825
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (56 (4 x14) Tablets)

Topcare®
health

 NDC: 76162-031-56

COMPARE TO THE ACTIVE INGREDIENT
IN MAXIMUM STRENGTH MUCINEX®*

MAXIMUM STRENGTH

Mucus ER
GUAIFENESIN
EXTENDED-RELEASE TABLETS 1200 mg

GUAIFENESIN 1200 mg - EXPECTORANT
RELIEVES CHEST CONGESTION

12
HOUR

For Day or Night

• Relieves Chest Congestion
• Thins & Loosens Mucus
  

56
EXTENDED-RELEASE TABLETS

 

 

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-031
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
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-031-56	4 in 1 CARTON	04/22/2026
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	ANDA210453	04/22/2026

Labeler - TOPCO ASSOCIATES LLC (006935977)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	ANALYSIS(76162-031) , MANUFACTURE(76162-031)