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Childrens Uniphed Nasal Decongestant

Medically reviewed on April 30, 2018

Dosage form: liquid
Ingredients: Pseudoephedrine hydrochloride 15mg in 5mL
Labeler: Rij Pharmaceutical Corporation
NDC Code: 53807-422


* 5 mL = one teaspoonful

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Drug Facts

Active ingredient (in each 5 mL*)

Pseudoephedrine HCl, USP 15 mg


* 5 mL = one teaspoonful

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

Warnings

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

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

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 15º - 30ºC (59º - 86ºF)

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

PRINCIPAL DISPLAY PANEL

CHILDRENS UNIPHED   NASAL DECONGESTANT
pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-422
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pseudoephedrine hydrochloride (Pseudoephedrine) Pseudoephedrine hydrochloride15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
edetate disodium 
FD&C blue no. 1 
FD&C red no. 40 
glycerin 
poloxamer 407 
polyethylene glycols 
povidone K90 
water 
saccharin sodium 
sodium benzoate 
sodium citrate 
sorbitol 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53807-422-04118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIOperations
Rij Pharmaceutical Corporation144679156manufacture(53807-422)

 
Rij Pharmaceutical Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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