272r Timely 49483-272 Guaifenesin 400 Mg Tablets

SPL v5

SPL

SPL Set ID d34ef2e8-adc2-48e5-a572-e354937daec6

Route

ORAL

Published

Effective Date 2015-11-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: TCL272 Shape: round Color: white Size: 12 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-04-16

Description

Active ingredient (in each immediate-release tablet) Guaifenesin 400 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

Dosage and Administration

Directions

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

Description

Active ingredient (in each immediate-release tablet) Guaifenesin 400 mg

Section 44425-7

Other information

• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

• keep in a dry place and do not expose to excessive heat

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if

• cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50567-7

When using this product

• do not exceed recommended dosage

• do not use for more than 7 days

Section 50569-3

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 excessive phlegm (mucus)

Section 51727-6

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

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-877-290-4008

Section 53414-9

If pregnant or breast-feeding, ask a healthcare professional before use.

Section 55105-1

Purpose

Expectorant

Section 55106-9

Active ingredient (in each immediate-release tablet)

Guaifenesin 400 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus

Dosage and Administration (34068-7)

Directions

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

Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

• keep in a dry place and do not expose to excessive heat

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

• do not exceed recommended dosage

• do not use for more than 7 days

Section 50569-3 (50569-3)

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 excessive phlegm (mucus)

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-877-290-4008

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a healthcare professional before use.

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

Active ingredient (in each immediate-release tablet)

Guaifenesin 400 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus", "34068-7": "Directions adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours. children under 12 years of age: do not use", "34071-1": "Warnings", "44425-7": "Other information • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) • keep in a dry place and do not expose to excessive heat", "50565-1": "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.", "50566-9": "Stop use and ask a doctor if • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "50567-7": "When using this product • do not exceed recommended dosage • do not use for more than 7 days", "50569-3": "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 excessive phlegm (mucus)", "51727-6": "Inactive ingredients colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid", "53413-1": "Questions or comments? Call 1-877-290-4008", "53414-9": "If pregnant or breast-feeding, ask a healthcare professional before use.", "55105-1": "Purpose Expectorant", "55106-9": "Active ingredient (in each immediate-release tablet) Guaifenesin 400 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:11.618938 · Updated: 2026-03-14T23:01:38.303933