Medi-first Sinus Decongestant Tablet, Film Coated
FDA Label NDC 47682-809

15 label sections · Submitted to the FDA by Unifirst First Aid Corporation · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Medi-first Sinus Decongestant (NDC 47682-809). 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 drug facts, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Otc - Purpose

Purpose

Nasal decongestant

Indications & Usage

Uses

Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

Warnings

Warnings

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.

Otc - Ask Doctor

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 dosage

Otc - Stop Use

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

Otc - Pregnancy Or Breast Feeding

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

Otc - 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).

Dosage & Administration

Directions

  • do not use more than directed

    • ​

    Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 doses in 24 hours.

    Children under 12 years: Ask a doctor

Other

Other information

  • store at room temperature 59°-86° F (15°-30° C)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredient

Inactive ingredients

croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

Medi-First Sinus Decongestant Label

100 Tablets

(100 x 1)

Medi-First®

Sinus Decongestant

Compare active ingredients to:

Sudafed® PE

Registered Trademark of Pfizer Consumer

Nasal Decongestant ● Phenylephrine HCl 10mg

Tamper Evident Unit Dose Packets

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