Guaifenesin Tablets, Usp 400 Mg

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg)

Inactive Ingredients

Maltodextrin Croscarmellose Sodium Water Silicon Dioxide Cellulose, Microcrystalline Stearic Acid Povidone K30

Identifiers & Packaging

Pill Appearance

Imprint: G400 Shape: capsule Color: white Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-02-07

Medication Information

Warnings and Precautions

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

Indications and Usage

Uses

Temporary symptomatic relief from congested chests and cough.

Dosage and Administration

Directions

Adults and children 12 years of age and over:take 1 caplet a day.
Children under 12 years:Do not use.
Do not exceed 4 doses in 24 hours.

Description

Active ingredient (in each caplet) Guaifenesin 400 mg

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 please consult your physician or healthcare provider.

Section 50567-7

When using this product

Do not exceed recommended dosage.
Do not consume alcohol, benzodiazepines or opioids.

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

Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, stearic acid, Purified water.

Section 53413-1

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

Section 53414-9

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

Section 55105-1

Purpose

Expectorant

Section 55106-9

Active ingredient (in each caplet)

Guaifenesin 400 mg

Section 60561-8

Other information

■ Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).

■ Keep in a dry place and do not expose to heat.

■ Read all product information before use.

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

Principal Display Panel

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary symptomatic relief from congested chests and cough.

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and over:take 1 caplet a day.
Children under 12 years:Do not use.
Do not exceed 4 doses in 24 hours.

Warnings and Precautions (34071-1)

Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

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 please consult your physician or healthcare provider.

Section 50567-7 (50567-7)

When using this product

Do not exceed recommended dosage.
Do not consume alcohol, benzodiazepines or opioids.

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

Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, stearic acid, Purified water.

Section 53413-1 (53413-1)

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

Active ingredient (in each caplet)

Guaifenesin 400 mg

Section 60561-8 (60561-8)

Other information

■ Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).

■ Keep in a dry place and do not expose to heat.

■ Read all product information before use.

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Temporary symptomatic relief from congested chests and cough.", "34068-7": "Directions Adults and children 12 years of age and over: take 1 caplet a day. Children under 12 years: Do not use. Do not exceed 4 doses in 24 hours.", "34071-1": "Warnings A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.", "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 please consult your physician or healthcare provider.", "50567-7": "When using this product Do not exceed recommended dosage. Do not consume alcohol, benzodiazepines or opioids.", "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 Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, stearic acid, Purified water.", "53413-1": "Questions or comments? Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Expectorant", "55106-9": "Active ingredient (in each caplet) Guaifenesin 400 mg", "60561-8": "Other information ■ Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F). ■ Keep in a dry place and do not expose to heat. ■ Read all product information before use. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING"}