Sudafed Sinus Congestion Tablet, Film Coated
FDA Label NDC 50580-363

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Sudafed Sinus Congestion (NDC 50580-363). 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 other, active ingredient (in each tablet), purpose, uses, otc - do not use, ask a doctor before use if you have, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

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

Otc - Do Not Use

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
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Otc - When Using

When using this product do not exceed recommended dose

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

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

Otc - 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. (1-800-222-1222)

Directions

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours
  • do not take more than 8 tablets in 24 hours
children ages 6 to 11 years
  • take 1 tablet every 4 to 6 hours
  • do not take more than 4 tablets in 24 hours
children under 6 yearsdo not use this product in children under 6 years of age

Other Information

  • store between 20 - 25°C (68 - 77°F)
  • do not use if blister unit is torn or broken
  • see side panel for lot number and expiration date

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

Questions Or Comments?

call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

PREVIOUSLY SUDAFED® CONGESTION
NDC 50580-363-02

SUDAFED®

SINUS
CONGESTION

Pseudoephedrine HCl 30 mg,
Nasal Decongestant

actual size

MAXIMUM STRENGTH

  • SINUS PRESSURE
  • SINUS CONGESTION

    • 24 TABLETS

    NON-DROWSY

    Principal Display Panel (Sudafed 01)

    Principal Display Panel (Sudafed 01)

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