Pseudoephedrine Hydrochloride
FDA Label NDC 37012-204

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shopko Stores Operating Co., Llc for the product Pseudoephedrine Hydrochloride (NDC 37012-204). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Pseudoephedrine HCl USP, 120 mg

Purpose

Nasal decongestant

Uses

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure

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.

Ask A Doctor Before Use If You Have

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

When Using This Product

  • do not use more than directed

Stop Use And Ask A Doctor If

  • symptoms do not get better within 7 days or occur with a fever
  • you get nervous, dizzy, or sleepless

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.

Directions

  • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

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, microcrystalline cellulose, magnesium stearate, titanium dioxide

Questions?

Call 1-800-406-7984

Principal Display Panel

SHOPKO®

Compare to the active ingredient of SUDAFED®12 Hour

12 Hour, Non-Drowsy

Nasal Decongestant

Pseudoephedrine HCl Extended-Release Tablets, USP 120 mg

Long-Acting Nasal Decongestant

Nasal & Sinus Congestion Due to Colds & Allergies

Sinus Pressure

Maximum Strength

Manufactured by: Ohm Laboratories Inc.

5089484/R0212

20's Blister Carton Label (Pse)

20's Blister Carton Label (Pse)

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