Guaifenesin 200mg

SPL v5

SPL

SPL Set ID 5c04a60e-8a73-48b2-88ec-3b0d4b597412

Route

ORAL

Published

Effective Date 2019-03-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (200 mg)

Inactive Ingredients

Silicon Dioxide Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: G2 Shape: round Color: white Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-03-01

Description

GUAIFENESIN 200 MG TABLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact

Purpose

Expectorant Guaifenesin 200 mg Tablets

Medication Information

Purpose

Expectorant

Guaifenesin 200 mg Tablets

Description

GUAIFENESIN 200 MG TABLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact

Uses

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

Section 42229-5

GUAIFENESIN 200 MG TABLETS

Marlex Pharmaceuticals, Inc.

----------

Drug Fact

Warnings

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)

Directions:

Do not take more than 6 doses in any 24-hour period.
This product is not intended for use in children under 12 years of age
Adults & children 12 years and over: 1 to 2 tablets every 4 hours
Children under 12 years: do not use

Other Information:

Store at 15°C-30°C (59°F-86°F)

Inactive Ingredients:

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

Principal Display Panel

NDC 10135-0681-01

Guaifenesin

200 mg

100 TABLETS

Stop Use and Ask A Doctor If

cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness.

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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding

ask a health professional before use.

Active Ingredient (in Each Tablet)

Guaifenesin 200mg

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

GUAIFENESIN 200 MG TABLETS

Marlex Pharmaceuticals, Inc.

----------

Drug Fact

Purpose

Expectorant

Guaifenesin 200 mg Tablets

Warnings

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)

Directions:

Do not take more than 6 doses in any 24-hour period.
This product is not intended for use in children under 12 years of age
Adults & children 12 years and over: 1 to 2 tablets every 4 hours
Children under 12 years: do not use

Other Information:

Store at 15°C-30°C (59°F-86°F)

Inactive Ingredients:

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10135-0681-01

Guaifenesin

200 mg

100 TABLETS

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness.

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

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.

If Pregnant Or Breast Feeding (If pregnant or breast- feeding)

ask a health professional before use.

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

Guaifenesin 200mg

Advanced Ingredient Data

[{"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": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive", "42229-5": "GUAIFENESIN 200 MG TABLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact", "Purpose": "Expectorant Guaifenesin 200 mg Tablets", "Warnings": "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)", "Directions:": "Do not take more than 6 doses in any 24-hour period. This product is not intended for use in children under 12 years of age Adults & children 12 years and over: 1 to 2 tablets every 4 hours Children under 12 years: do not use", "Other Information:": "Store at 15°C-30°C (59°F-86°F)", "Inactive Ingredients:": "Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev: 02/19TCL", "PRINCIPAL DISPLAY PANEL": "NDC 10135-0681-01 Guaifenesin 200 mg 100 TABLETS", "Stop use and ask a doctor if": "cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. ", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center right away.", "If pregnant or breast- feeding": "ask a health professional before use.", "Active ingredient (in each tablet)": "Guaifenesin 200mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:41.544874 · Updated: 2026-03-14T23:03:53.608631