DR SIMI MUCUS RELIEF EXPECTORANT- guaifenesin tablet, extended release

Dr Simi Mucus Relief Expectorant by

Drug Labeling and Warnings

Dr Simi Mucus Relief Expectorant by is a Otc medication manufactured, distributed, or labeled by Farmacias De Similares TX LLC, Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each extended-release tablet)

• Guaifenesin 1200 mg

Purpose

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

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 accompained by too much phlegm (mucus).

Stop use and ask a doctor if

• Cough lasts more than 7 days, come 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

​Keep out of reach of children

Overdosage

in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Do not crush, chew, or break tablet.
• Take with a full glass of water.
• This product can be administered without regard for 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.
• Childrens under 12 years of age: do not use.

Other information

• Store between 20-25°C (68-77°F)
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive ingredients

Carbomer homopolymer type B, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Sodium starch glycolate.

Questions or comments?

(855)-280-1079

SPL UNCLASSIFIED SECTION

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

EXP:

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PRINCIPAL DISPLAY PANEL

DR SIMI

NDC: 85786-301-14

Maximum Strength / Expectorant

Mucus Relief

Guaifenesin 1200 mg

Relieves Chest Congestion

Thins and Loosens Mucus

Immediate and Extended Release

14 Tablets

Extended Release

Bi-Layer Tablets

INGREDIENTS AND APPEARANCE

DR SIMI MUCUS RELIEF EXPECTORANT 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-301
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
SODIUM STARCH GLYCOLATE TYPE B (UNII: SP4S77AHO6)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	G;1200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-301-14	14 in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/15/2025

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Limited		918609236	analysis(85786-301) , label(85786-301) , manufacture(85786-301) , pack(85786-301)