Pseudoephedrine Hydrochloride

SPL v5

SPL

SPL Set ID 0a2672f0-4e6f-48c9-8571-2d09f06253d7

Route

ORAL

Published

Effective Date 2026-01-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Pseudoephedrine (120 mg)

Inactive Ingredients

Ricinus Communis (castor) Seed Oil Silica Hydroxypropyl Methylcellulose Magnesium Stearate Microcrystalline Cellulose Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 204 Shape: capsule Color: white Size: 18 mm Score: 1

Marketing Status

ANDA Active Since 2006-04-28

Description

Drug Facts

Purpose

Nasal decongestant

How Supplied

Product: 50090-5554 NDC: 50090-5554-0 10 TABLET, FILM COATED in a BLISTER PACK

Medication Information

Purpose

Nasal decongestant

How Supplied

Product: 50090-5554

NDC: 50090-5554-0 10 TABLET, FILM COATED in a BLISTER PACK

Description

Drug Facts

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50567-7

When using this product do not exceed recommended dosage

Section 50570-1

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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

adults and children 12 years and over	take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours
children under 12 years	do not use this product in children under 12 years of age

Questions?

call 1-800-406-7984

Other Information

store at 59° to 77° F in a dry place. Protect from light
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients

castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

Pseudoephedrine Hydrochloride

Active Ingredient (in Each Tablet)

Pseudoephedrine HCl, USP 120 mg

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

Structured Label Content

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves sinus congestion and pressure

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50570-1 (50570-1)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Nasal decongestant

Directions

adults and children 12 years and over	take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours
children under 12 years	do not use this product in children under 12 years of age

Questions?

call 1-800-406-7984

How Supplied (HOW SUPPLIED)

Product: 50090-5554

NDC: 50090-5554-0 10 TABLET, FILM COATED in a BLISTER PACK

Other Information (Other information)

store at 59° to 77° F in a dry place. Protect from light
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients (Inactive ingredients)

castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide

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

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

Pseudoephedrine Hydrochloride (PSEUDOEPHEDRINE HYDROCHLORIDE)

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

Pseudoephedrine HCl, USP 120 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

[{"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "120", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "RICINUS COMMUNIS (CASTOR) SEED OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICA", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL METHYLCELLULOSE", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "50567-7": "When using this product do not exceed recommended dosage", "50570-1": "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 the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Nasal decongestant", "Directions": "adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age", "Questions?": "call 1-800-406-7984", "HOW SUPPLIED": "Product: 50090-5554 NDC: 50090-5554-0 10 TABLET, FILM COATED in a BLISTER PACK", "Other information": "store at 59° to 77° F in a dry place. Protect from light TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.", "Inactive ingredients": "castor oil, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever", "Active ingredient (in each tablet)": "Pseudoephedrine HCl, USP 120 mg", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:17.888694 · Updated: 2026-03-14T23:12:38.341862