drug facts

drug facts

SPL v2

SPL

SPL Set ID 0bf70fb4-d3c8-476d-b864-4eadc697a7d8

Route

oral

Published

Effective Date 2025-12-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

guaifenesin (400 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: PH063 Shape: capsule Color: white Size: 17 mm Score: 2

Marketing Status

otc monograph drug active Since 2018-05-01

Purpose

Expectorant

Description

Guaifenesin 400mg

Medication Information

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 too much phlegm (mucus)

Active Ingredient

Guaifenesin 400mg

Uses

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

Purpose

Expectorant

Directions

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

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 ½ tablet every 4 hours as needed
children under 6 years of age	consult a doctor

Other Information

store at room temperature (15°-30°C)
Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive Ingredients

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

Description

Guaifenesin 400mg

Questions?

Adverse drug event call (866) 562-2756 Mon-Fri 8 AM to 4 PM

Section 51945-4

PHARBEST

NDC 16103-379-04

Manufactured in the USA

Immediate Release

PHARBINEX

*COMPARE TO the active ingredient in MUCINEX^® Tablets

Guaifenesin 400mg

Expectorant

30 TABLETS

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 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.

Structured Label Content

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 too much phlegm (mucus)

Active Ingredient (Active Ingredient (in each tablet))

Guaifenesin 400mg

Uses

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

Purpose

Expectorant

Directions

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

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 ½ tablet every 4 hours as needed
children under 6 years of age	consult a doctor

Other Information (Other information)

store at room temperature (15°-30°C)
Tamper Evident: do not use if safety seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

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

Questions?

Adverse drug event call (866) 562-2756 Mon-Fri 8 AM to 4 PM

Section 51945-4 (51945-4)

PHARBEST

NDC 16103-379-04

Manufactured in the USA

Immediate Release

PHARBINEX

*COMPARE TO the active ingredient in MUCINEX^® Tablets

Guaifenesin 400mg

Expectorant

30 TABLETS

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 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.

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "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, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps make cough more productive", "51945-4": "PHARBEST NDC 16103-379-04 Manufactured in the USA Immediate Release PHARBINEX *COMPARE TO the active ingredient in MUCINEX ® Tablets Guaifenesin 400mg Expectorant 30 TABLETS", "Purpose": "Expectorant", "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 too much phlegm (mucus)", "Directions": "take with a full glass of water do not exceed 6 doses in 24 hours 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 ½ tablet every 4 hours as needed children under 6 years of age consult a doctor", "Questions?": "Adverse drug event call (866) 562-2756 Mon-Fri 8 AM to 4 PM", "Other information": "store at room temperature (15°-30°C) T amper Evident: do not use if safety seal under cap is broken or missing", "Inactive ingredients": "magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid.", "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 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.", "Active Ingredient (in each tablet)": "Guaifenesin 400mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:54.203694 · Updated: 2026-03-14T23:11:53.041179