Pharbinex Dm Tablet

SPL v3

SPL

SPL Set ID 8d71db43-da87-45ee-aa4a-7e870bc5016d

Route

ORAL

Published

Effective Date 2025-12-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (400 mg) Dextromethorphan (20 mg)

Inactive Ingredients

Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone, Unspecified Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: PH073 Shape: capsule Color: white Size: 18 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-04-02

Description

Guaifenesin 400mg Dextromethorphan HBr 20mg

Purpose

Expectorant Cough suppressant

Medication Information

Purpose

Expectorant

Cough suppressant

Description

Guaifenesin 400mg Dextromethorphan HBr 20mg

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
helps make cough more productive
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold

Section 51945-4

PHARBEST

NDC 16103-381-04

Manufactured in the USA

Immediate Release

PHARBINEX-DM

*Compare to the active ingredient in MUCINEX ^® DM Tablets

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Expectorant &

Cough Suppressant

30 TABLETS

Warnings

Do not use

if you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease) or for 2 weeks after stopping MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product.

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

Drug Facts

Questions?

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

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 celluclose, povidone, silicon dioxide, stearic acid.

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 Ingredients (in Each Tablet)

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
helps make cough more productive
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold

Section 51945-4 (51945-4)

PHARBEST

NDC 16103-381-04

Manufactured in the USA

Immediate Release

PHARBINEX-DM

*Compare to the active ingredient in MUCINEX ^® DM Tablets

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Expectorant &

Cough Suppressant

30 TABLETS

Purpose

Expectorant

Cough suppressant

Warnings

Do not use

if you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease) or for 2 weeks after stopping MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product.

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

Drug Facts

Questions?

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

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 celluclose, povidone, silicon dioxide, stearic acid.

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.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "20", "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 temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold", "51945-4": "PHARBEST NDC 16103-381-04 Manufactured in the USA Immediate Release PHARBINEX-DM *Compare to the active ingredient in MUCINEX ® DM Tablets Guaifenesin 400mg Dextromethorphan HBr 20mg Expectorant & Cough Suppressant 30 TABLETS", "Purpose": "Expectorant Cough suppressant", "Warnings": "Do not use if you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease) or for 2 weeks after stopping MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product.", "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) Tamper Evident: do not use if safety seal under cap is broken or missing", "Inactive ingredients": "magnesium stearate, maltodextrin, microcrystalline celluclose, povidone, silicon dioxide, stearic acid.", "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 ingredients (in each tablet)": "Guaifenesin 400mg Dextromethorphan HBr 20mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:54.218060 · Updated: 2026-03-14T23:11:53.041179