DR. SIMI MUCUS RELIEF- guaifenesin tablet, extended release

Drug Labeling and Warnings

Drug Details [pdf]

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

■ store between 20-25°C (68-77°F)
■ retain carton for complete product information and warnings

Inactive ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions or comments?

855-280-1079

Principal Display Panel

NDC: 85786-302-40

DR. SIMI

Mucus Relief

Guaifenesin Extended-Release
Tablets, 600 mg

Expectorant

12 hour

Relieves Chest congestion
Thins & Loosens mucus
Immediate and Extended Release

40 EXTENDED-RELEASE TABLETS

†Compare to the active ingredient in Mucinex®

†This product is not manufactured or distributed by Reckitt Benckiser, distributor of Mucinex®

DO NOT USE IF BLISTER UNITS ARE TORN OR BROKEN

Made in India

Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com

Carton labeling

INGREDIENTS AND APPEARANCE

DR. SIMI MUCUS RELIEF 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-302
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
MAGNESIUM STEARATE (UNII: 70097M6I30)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-302-40	2 in 1 CARTON	04/08/2026
1		20 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	ANDA213420	04/08/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	manufacture(85786-302)

Establishment
Name	Address	ID/FEI	Business Operations
AAA Pharmaceutical, Inc.		181192162	pack(85786-302)