Pseudoephedrine Hydrochloride

Label at a glance#

Contacts and useful links#

PhoneLabel contact(800) 231-4670

Websitewww.majorpharmaceuticals.comwww.majorpharmaceuticals.com

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Pseudoephedrine HCl 60 mg

OTC - PURPOSE SECTION

Purpose

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose.

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
• children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

• store in a dry place at 15° – 30°C (59° – 86°F)
• use by expiration date on package

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 231-4670

SPL UNCLASSIFIED SECTION

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

DISTRIBUTED BY: MAJOR® PHARMACEUTICALS
INDIANAPOLIS, IN 46268
www.majorpharmaceuticals.com

Pseudoephedrine Hydrochloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

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FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

• Pseudoephedrine Hydrochloride
• PSEUDOEPHEDRINE
• LACTOSE MONOHYDRATE
• ANHYDROUS LACTOSE
• CROSCARMELLOSE SODIUM
• CROSCARMELLOSE
• SILICA
• CELLULOSE, MICROCRYSTALLINE
• MAGNESIUM STEARATE
• STEARIC ACID

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.