Childrens Uniphed
FDA Label NDC 53807-422

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Childrens Uniphed (NDC 53807-422). 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 5 ml** 5 ml = one teaspoonful), 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 5 Ml** 5 Ml = One Teaspoonful)

Pseudoephedrine HCl, USP 15 mg

Purpose

Nasal Decongestant

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis
  • temporarily relieves sinus congestion and pressure
  • promotes nasal and/or sinus drainage

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 giving 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 use more than directed

Stop Use And Ask A Doctor If

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

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

  • take every 4 to 6 hours
  • do not take more than 4 doses in 24 hours
    • children under 2 years of ageask a doctor
    children 2 to under 6 years of ageone (1) teaspoonful
    children 6 to under 12 years of agetwo (2) teaspoonfuls
    adults and children 12 years of age and overfour (4) teaspoonfuls

Other Information

  • TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing
  • protect from light
  • each teaspoon (5 mL) contains: sodium 4 mg
  • Store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

citric acid, edetate disodium, FD&C Red #40, FD&C blue #1, flavor, glycerin, poloxamer, polyethylene glycol, povidone K-90, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, and water

* Please review the disclaimer below.