Medi-first Plus Sinus Decongestant Tablet, Film Coated
FDA Label NDC 47682-990

Full FDA labeling including 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 Plus Sinus Decongestant (NDC 47682-990). 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, do not use, ask a doctor before use if you have, when using this product, 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

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: Do not give to children under 12 years of age

Active Ingredient (In Each Tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

Temporarily relieves

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

■ sinus congestion and pressure

Promotes nasal and/or sinus drainage.

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

When Using This Product

  • do not exceed recommended dosage

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

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

Directions

  • do not use more than directed

Other Information

  • read all product information before using
  • contains FD&C yellow # 6 (tartrazine)
  • store at room temperature 59°-86° F (15°-30° C)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

carnauba wax*, croscarmellose sodium, dicalcium phosphate*, FD&C red #40, FD&C yellow # 6, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide*, stearic acid*, titanium dioxide

*may contain

Otc - Questions

Questions or comments? 1-800-634-7680

Principal Display Panel - 208R Mf Sinus Decongestant Label

24 Tablets

(24 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

* Please review the disclaimer below.