Dover Sudanyl Pe Tablet, Film Coated
FDA Label NDC 47682-162

17 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 Dover Sudanyl Pe (NDC 47682-162). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (in each tablet)

Phenylephrine HCl 5mg

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 - When Using

When using this product

■ do not exceed recommended dosage

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 - 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

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 2 tablets every 4-6 hours. Do not take more than 12 tablets in 24 hours.

    Children under 12 years:

    Ask a doctor

Other Safety Information

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

Otc - Questions

Questions or comments? 1-800-634-7680

205R Medique Medi-Phenyl Label

Medique®
Medi-Phenyl
Pseudoephedrine Free

Sin seudoefedrina

Nasal Decongestant • Phenylephrine HCl 5mg

Decongestivo Nasal • Hidrocloruro de fenilefrina 5 mg

Pull to Open

Tire Para Abrir

500 Tablets
(250 x 2)
Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

Dover Sudanyl Label

Dover Sudanyl PE
Nasal and Nasal Decongestant
Non-Drowsy, Sugar Free
Phenylephrine HCl 5mg
Dover Pharmaceutical
Products of the highest quality and effectiveness
Tamper Resistant
Sealed Packets
Unit Dose Packs
500 Tablets
(250 Packets of 2)

* Please review the disclaimer below.