Guaifenesin Extended-release Bi-layer Tablets, 1200 Mg

SPL v1

SPL

SPL Set ID d995a6a5-d68b-44e4-9281-32c5417fb5e3

Route

ORAL

Published

Effective Date 2025-04-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg)

Inactive Ingredients

Hypromelloses Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Sodium Starch Glycolate Type A Potato Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: G;1200 Shape: oval Color: white Size: 21 mm Score: 1

Marketing Status

ANDA Active Since 2020-12-18

Description

Guaifenesin 1200 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

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

Warnings

Do not use

for children under 12 years of age

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
children under 12 years of age:do not use

Questions?

call toll-free 1-844-912-4012

Other Information

store at 20-25°C (68-77°F)
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

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

Principal Display Panel

NDC 37835-412-28

Compare to the active ingredients in Mucinex ^®*

MUCUS RELIEF

Guaifenesin 1200 mg

EXPECTORANT

Extended-Release Bi-Layer Tablets

Relieves Chest Congestion
Thins and Loosens Mucus
Immediate and Extended Release

28 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Mucinex ^®.

Distributed by:

BI-MART

Eugene, OR 97402

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.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

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)

Active Ingredient (in Each Extended Release Bi Layer Tablet)

Guaifenesin 1200 mg

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

Purpose

Expectorant

Warnings

Do not use

for children under 12 years of age

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
children under 12 years of age:do not use

Questions?

call toll-free 1-844-912-4012

Other Information (Other information)

store at 20-25°C (68-77°F)
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 37835-412-28

Compare to the active ingredients in Mucinex ^®*

MUCUS RELIEF

Guaifenesin 1200 mg

EXPECTORANT

Extended-Release Bi-Layer Tablets

Relieves Chest Congestion
Thins and Loosens Mucus
Immediate and Extended Release

28 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Mucinex ^®.

Distributed by:

BI-MART

Eugene, OR 97402

Stop Use and Ask A Doctor If (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.

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

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 accompanied by too much phlegm (mucus)

Active Ingredient (in Each Extended Release Bi Layer Tablet) (Active ingredient (in each extended-release bi-layer tablet))

Guaifenesin 1200 mg

Advanced Ingredient Data

[{"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "Purpose": "Expectorant", "Warnings": "Do not use for children under 12 years of age", "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 children under 12 years of age: do not use", "Questions?": "call toll-free 1-844-912-4012", "Other information": "store at 20-25°C (68-77°F) DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED", "Inactive ingredients": "carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.", "PRINCIPAL DISPLAY PANEL": "NDC 37835-412-28 Compare to the active ingredients in Mucinex ® * MUCUS RELIEF Guaifenesin 1200 mg EXPECTORANT Extended-Release Bi-Layer Tablets Relieves Chest Congestion Thins and Loosens Mucus Immediate and Extended Release 28 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Mucinex ® . Distributed by: BI-MART Eugene, OR 97402", "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.", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "If pregnant or breast-feeding,": "ask a health professional before use.", "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)", "Active ingredient (in each extended-release bi-layer tablet)": "Guaifenesin 1200 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:02.319263 · Updated: 2026-03-14T23:08:30.723878