Maximum Strength Expectorant Mucus Relief Guaifenesin 1200

Maximum Strength Expectorant Mucus Relief Guaifenesin 1200
SPL v1
SPL
SPL Set ID 3c6d0e75-a685-6020-e063-6294a90a5c1b
Route
ORAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg)
Inactive Ingredients
Sodium Starch Glycolate Type B Carbomer Homopolymer Type B (allyl Pentaerythritol Or Allyl Sucrose Crosslinked) Microcrystalline Cellulose Hypromellose, Unspecified Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: G;1200 Shape: oval Color: white Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-15

Description

Active ingredient (in each extended-release tablet) Guaifenesin 1200 mg

Purpose

Purpose Expectorant


Medication Information

Purpose

Purpose

  • Expectorant
Dosage and Administration
  • 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.
Description

Active ingredient (in each extended-release tablet) Guaifenesin 1200 mg

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Section 42229-5

Distributed by: FARMACIAS DE SIMILARES TX LLC

800 Brazos St Ste 260, Austin, TX, 78701, USA.

[email protected]

www.drsimi.com

LOT#

EXP:

PEEL BACK for more DRUG FACTS

Section 51945-4

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

Warnings

Warnings

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.
Do Not Use
  • For children under 12 years of age.
Drug Facts

Active ingredient (in each extended-release tablet)

  • Guaifenesin 1200 mg

Overdosage

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

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

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

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).

Structured Label Content

Uses
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Dosage and Administration (34068-7)
  • 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.
Section 42229-5 (42229-5)

Distributed by: FARMACIAS DE SIMILARES TX LLC

800 Brazos St Ste 260, Austin, TX, 78701, USA.

[email protected]

www.drsimi.com

LOT#

EXP:

PEEL BACK for more DRUG FACTS

Section 51945-4 (51945-4)

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

Purpose

Purpose

  • Expectorant
Warnings

Warnings

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.
Do Not Use (Do not use)
  • For children under 12 years of age.
Drug Facts

Active ingredient (in each extended-release tablet)

  • Guaifenesin 1200 mg

Overdosage

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

Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

(855)-280-1079

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use

Keep Out of Reach of Children (Keep out of reach of children)

​Keep out of reach of children

Ask A Doctor Before Use If You Have (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).

Advanced Ingredient Data


Raw Label Data

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