Guaifenesin Tablets 400 Mg

SPL v2

SPL

SPL Set ID e5004c10-3877-c199-e053-2a95a90aa8ac

Route

ORAL

Published

Effective Date 2022-07-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg)

Inactive Ingredients

Maltodextrin Silicon Dioxide Stearic Acid Povidone

Identifiers & Packaging

Pill Appearance

Imprint: A;G1 Shape: round Color: white Size: 10 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-08-05

Description

Caution: do not use if imprinted seal under cap is broken or missing.

Medication Information

Recent Major Changes

Caution: do not use if imprinted seal under cap is broken or missing.

Warnings and Precautions

Warnings

Ask 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)

Stop use and ask a doctor if

Symptoms are accompanied by fever, rash or persistent headache
cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition

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

Indications and Usage

Use

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

Dosage and Administration

Directions

Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
Children 6 to under 12 years of age: take 1/2 tablet every 4 hours as needed
Children under 6 years of age: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Description

Caution: do not use if imprinted seal under cap is broken or missing.

Section 42229-5

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Made in USA

Rev.: 05/2022

Section 44425-7

Other Information

Store at 15°-30°C (59°-86°F)

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center immediately.

Section 51727-6

Inactive Ingredients

Maltodextrin, Povidone, Silicon dioxide and Stearic acid

Section 51945-4

NDC 24689-144-01

Guaifenesin Tablets 400 mg

Expectorant

100 Tablets

Section 53413-1

Questions or concerns?

1-855-642-2594

Section 55105-1

Purpose

Expectorant

Section 55106-9

Active Ingredient (per tablet)

Guaifenesin USP 400 mg

Structured Label Content

Recent Major Changes (34066-1)

Caution: do not use if imprinted seal under cap is broken or missing.

Indications and Usage (34067-9)

Use

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

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
Children 6 to under 12 years of age: take 1/2 tablet every 4 hours as needed
Children under 6 years of age: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Warnings and Precautions (34071-1)

Warnings

Ask 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)

Stop use and ask a doctor if

Symptoms are accompanied by fever, rash or persistent headache
cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition

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

Section 42229-5 (42229-5)

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Made in USA

Rev.: 05/2022

Section 44425-7 (44425-7)

Other Information

Store at 15°-30°C (59°-86°F)

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive Ingredients

Maltodextrin, Povidone, Silicon dioxide and Stearic acid

Section 51945-4 (51945-4)

NDC 24689-144-01

Guaifenesin Tablets 400 mg

Expectorant

100 Tablets

Section 53413-1 (53413-1)

Questions or concerns?

1-855-642-2594

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

Active Ingredient (per tablet)

Guaifenesin USP 400 mg

Advanced Ingredient Data

[{"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34066-1": "Caution: do not use if imprinted seal under cap is broken or missing.", "34067-9": "Use helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps make coughs more productive", "34068-7": "Directions Adults and children 12 years of age and over : take 1 tablet every 4 hours as needed Children 6 to under 12 years of age : take 1/2 tablet every 4 hours as needed Children under 6 years of age : consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor", "34071-1": "Warnings Ask 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) Stop use and ask a doctor if Symptoms are accompanied by fever, rash or persistent headache cough persists for more than 1 week or tends to recur A persistent cough may be a sign of a serious condition If pregnant or breast-feeding , ask a healthcare professional before use.", "42229-5": "Manufactured by: APNAR PHARMA LLP East Windsor, NJ 08520 Made in USA Rev.: 05/2022", "44425-7": "Other Information Store at 15°-30°C (59°-86°F)", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center immediately.", "51727-6": "Inactive Ingredients Maltodextrin, Povidone, Silicon dioxide and Stearic acid", "51945-4": "NDC 24689-144-01 Guaifenesin Tablets 400 mg Expectorant 100 Tablets", "53413-1": "Questions or concerns? 1-855-642-2594", "55105-1": "Purpose Expectorant", "55106-9": "Active Ingredient (per tablet) Guaifenesin USP 400 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:34.408484 · Updated: 2026-03-14T23:01:27.375563