Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 552b0c0e-00f9-498b-8786-ad242703e04b

Route

ORAL

Published

Effective Date 2025-08-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Guaifenesin (400 mg)

Inactive Ingredients

Silicon Dioxide Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: TCL272 Shape: round Color: white Size: 13 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2020-02-28 Until 2026-06-30

Description

Guaifenesin 400 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

Directions

do not exceed 6 tablets in 24 hours
take with a full glass of water
adults and children 12 years of age and older
- take 1 tablet every 4 hours while symptoms persist
children under 12 years of age: do not use

Package Label

GOOD SENSE Mucus Relief Tablets

Other Information

store between 20-25ºC (68-77ºF)

Inactive Ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Immediate Acting

Mucus Relief

Expectorant

Guaifenesin 400 mg TABLETS

Relieves Chest Congestion
Thin & Loosens Mucus

Dye-Free

TABLETS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Geiss, Destin & Dunn. Inc., A Perrigo Company

Peachtree City, GA 30269

www.PerrigoDirect.com

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 condition.

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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough accopanied 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 makes coughs more productive.

Purpose

Expectorant

Directions

do not exceed 6 tablets in 24 hours
take with a full glass of water
adults and children 12 years of age and older
- take 1 tablet every 4 hours while symptoms persist
children under 12 years of age: do not use

Package Label

GOOD SENSE Mucus Relief Tablets

Other Information (Other information)

store between 20-25ºC (68-77ºF)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Immediate Acting

Mucus Relief

Expectorant

Guaifenesin 400 mg TABLETS

Relieves Chest Congestion
Thin & Loosens Mucus

Dye-Free

TABLETS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

Geiss, Destin & Dunn. Inc., A Perrigo Company

Peachtree City, GA 30269

www.PerrigoDirect.com

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 condition.

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.)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Guaifenesin 400 mg

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 accopanied by too much phlegm (mucus)

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "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 makes coughs more productive.", "Purpose": "Expectorant", "Directions": "do not exceed 6 tablets in 24 hours take with a full glass of water adults and children 12 years of age and older take 1 tablet every 4 hours while symptoms persist children under 12 years of age: do not use", "Package Label": "GOOD SENSE Mucus Relief Tablets", "Other information": "store between 20-25ºC (68-77ºF)", "Inactive ingredients": "colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "Immediate Acting Mucus Relief Expectorant Guaifenesin 400 mg TABLETS Relieves Chest Congestion Thin & Loosens Mucus Dye-Free TABLETS TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: Geiss, Destin & Dunn. Inc., A Perrigo Company Peachtree City, GA 30269 www.PerrigoDirect.com", "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 condition.", "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 (1-800-222-1222) right away.", "Active ingredient (in each tablet)": "Guaifenesin 400 mg", "Ask a doctor before use if you have": "persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough accopanied by too much phlegm (mucus)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:43.380134 · Updated: 2026-03-14T23:09:39.646164