Gencare Mucus Relief guaifenesin 1200mg

SPL v1

SPL

SPL Set ID d635b228-a51f-42d9-885c-3cd566fd352b

Route

ORAL

Published

Effective Date 2025-12-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Pentaerythritol Or Allyl Sucrose Crosslinked) Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: G;1200 Shape: oval Color: white Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2025-12-04

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

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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
•
children under 12 years of age: do not use

Do Not Use

• for children under 12 years of age

Other Information

• store between 20°-25°C (68°-77°F)

Inactive Ingredients

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

Questions Or Comments?

Call 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST or www.gencare.health

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 right away (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)

Ndc 72090 012 02 (30ct Hdpe Bottle)

Ndc 72090 012 03 (50ct Hdpe Bottle)

Active Ingredient (in Each Extended Release 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

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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
•
children under 12 years of age: do not use

Do Not Use (Do not use)

• for children under 12 years of age

Other Information (Other information)

• store between 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST or www.gencare.health

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 right away (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)

Ndc 72090 012 02 (30ct Hdpe Bottle) (NDC 72090-012-02 (30ct HDPE Bottle))

Ndc 72090 012 03 (50ct Hdpe Bottle) (NDC 72090-012-03 (50ct HDPE Bottle))

Active Ingredient (in Each Extended Release Tablet) (Active ingredient (in each extended-release tablet))

Guaifenesin 1200 mg

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)", "unii": "K6MOM3T5YL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "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": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "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 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. • children under 12 years of age: do not use", "Do not use": "• for children under 12 years of age", "Other information": "• store between 20°-25°C (68°-77°F)", "Inactive ingredients": "carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "Questions or comments?": "Call 1-732-698-5070 Monday through Friday 9 AM to 5 PM EST or www.gencare.health", "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 right away (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 tablet)": "Guaifenesin 1200 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:30.764812 · Updated: 2026-03-14T23:11:02.639613