Major 44-588 - DailyMed Details

Major 44-588

SPL v2

SPL

SPL Set ID 15c87250-7c30-4565-b451-b87c6754a371

Route

ORAL

Published

Effective Date 2017-08-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (200 mg)

Inactive Ingredients

Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone Stearic Acid Fd&c Red No. 40 Silicon Dioxide

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH FINAL Active Since 2010-08-12

Description

Guaifenesin 200 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 200 mg

Uses

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

Section 51945-4

DRUG: Guaifenesin

GENERIC: Guaifenesin

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-511-02

COLOR: pink

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: 44;588

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

GUAIFENESIN 200mg in 1

INACTIVE INGREDIENT(S):

FD&C RED NO. 40
MAGNESIUM STEARATE
STEARIC ACID
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MALTODEXTRIN
SILICON DIOXIDE

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

Other Information

store at 25ºC (77ºF); excursions permitted between 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

Questions Or Comments?

(800) 616-2471

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

Uses

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

Section 51945-4 (51945-4)

DRUG: Guaifenesin

GENERIC: Guaifenesin

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-511-02

COLOR: pink

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: 44;588

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

GUAIFENESIN 200mg in 1

INACTIVE INGREDIENT(S):

FD&C RED NO. 40
MAGNESIUM STEARATE
STEARIC ACID
POVIDONE
CELLULOSE, MICROCRYSTALLINE
MALTODEXTRIN
SILICON DIOXIDE

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

Other Information (Other information)

store at 25ºC (77ºF); excursions permitted between 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

Questions Or Comments? (Questions or comments?)

(800) 616-2471

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": "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": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "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 passageways of bothersome mucus and make coughs more productive", "51945-4": "DRUG: Guaifenesin GENERIC: Guaifenesin DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 49349-511-02 COLOR: pink SHAPE: ROUND SCORE: No score SIZE: 10 mm IMPRINT: 44;588 PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): GUAIFENESIN 200mg in 1 INACTIVE INGREDIENT(S): FD&C RED NO. 40 MAGNESIUM STEARATE STEARIC ACID POVIDONE CELLULOSE, MICROCRYSTALLINE MALTODEXTRIN SILICON DIOXIDE", "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", "Other information": "store at 25ºC (77ºF); excursions permitted between 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", "Questions or comments?": "(800) 616-2471", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:23.610124 · Updated: 2026-03-14T22:54:48.761962