Nasal Decongestant Tablet, Extended Release
FDA Label NDC 70677-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services for the product Nasal Decongestant (NDC 70677-0001). 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, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, 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 HCI, 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

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 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 (1-800-222-1222).

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

†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Sudafed® 12 Hour.

Keep the carton. It contains important information. See end panel for expiration date.

R0418

McKESSON

Another Quality Product

Distributed by Mckesson

One Post Street, San Francisco, CA 94104

Money Back Guarantee

Please visit us at www.sunmarkbrand.com

Package/Label Principal Display Panel

Sunmark®

COMPARE TO SUDAFED® 12 HOUR ACTIVE INGREDIENT†

NDC 70677-0001-1

nasal decongestant

Pseudoephedrine Hydrochloride 120 mg

Extended-Release Tablets, USP

Long-Acting Nasal Decongestant

Non-drowsy

nasal & sinus congestion due to colds & allergies,

sinus pressure, maximum strength

  •  Actual Size 12 HOUR

    • 10 COATED CAPSULE-SHAPED TABLETS 120 mg EACH

* Please review the disclaimer below.