DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (200 mg)

Inactive Ingredients

Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 44;588 Shape: round Color: pink Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2008-01-07

Medication Information

Purpose

Expectorant

Description

Guaifenesin 200 mg

Use(s)

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

Directions

do not exceed 6 doses in 24 hours
take with a full glass of water

adults and children 12 years

of age and over

1 to 2 tablets every

4 hours

children 6 to under 12 years

of age

½ to 1 tablet every

4 hours

children under 6 years of age

consult a physician

Questions?

To Report Adverse Drug Event Call: (800) 616-2471

Other Information

store at controlled room temperature 15º-30ºC (59º-86ºF)
use by expiration date on package

Inactive Ingredients

FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NDC 54868-5847-0

GUAIFENESIN TABLETS

Guaifenesin 200 mg

Expectorant

Relieves Chest Congestion
Thins and Loosens Mucus

100 Tablets Immediate Release

50844 REV0510A58812

Distributed by MAJOR PHARMACEUTICALS

31788 Enterprise Drive,

Livonia, MI 48150 USA

Re-Order No. 238163 M-17 Rev. 11/10

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

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

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 illness.

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 right away.

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)

Active Ingredient (in Each Immediate Release Tablet)

Guaifenesin 200 mg

Structured Label Content

Use(s)

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

Purpose

Expectorant

Directions

do not exceed 6 doses in 24 hours
take with a full glass of water

adults and children 12 years

of age and over

1 to 2 tablets every

4 hours

children 6 to under 12 years

of age

½ to 1 tablet every

4 hours

children under 6 years of age

consult a physician

Questions?

To Report Adverse Drug Event Call: (800) 616-2471

Other Information (Other information)

store at controlled room temperature 15º-30ºC (59º-86ºF)
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NDC 54868-5847-0

GUAIFENESIN TABLETS

Guaifenesin 200 mg

Expectorant

Relieves Chest Congestion
Thins and Loosens Mucus

100 Tablets Immediate Release

50844 REV0510A58812

Distributed by MAJOR PHARMACEUTICALS

31788 Enterprise Drive,

Livonia, MI 48150 USA

Re-Order No. 238163 M-17 Rev. 11/10

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

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

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 illness.

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 right away.

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 accompanied by too much phlegm (mucus)

Active Ingredient (in Each Immediate Release Tablet) (Active ingredient (in each immediate-release tablet))

Guaifenesin 200 mg

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"Use(s)": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "Purpose": "Expectorant", "Directions": "do not exceed 6 doses in 24 hours take with a full glass of water adults and children 12 years of age and over 1 to 2 tablets every 4 hours children 6 to under 12 years of age ½ to 1 tablet every 4 hours children under 6 years of age consult a physician ", "Questions?": "To Report Adverse Drug Event Call: (800) 616-2471", "Other information": "store at controlled room temperature 15º-30ºC (59º-86ºF) use by expiration date on package", "Inactive ingredients": "FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid", "Principal Display Panel": "The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available. NDC 54868-5847-0 GUAIFENESIN TABLETS Guaifenesin 200 mg Expectorant Relieves Chest Congestion Thins and Loosens Mucus 100 Tablets Immediate Release 50844 REV0510A58812 Distributed by MAJOR PHARMACEUTICALS 31788 Enterprise Drive, Livonia, MI 48150 USA Re-Order No. 238163 M-17 Rev. 11/10 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146", "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 illness.", "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 right away.", "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)", "Active ingredient (in each immediate-release tablet)": "Guaifenesin 200 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information