Childrens Uniphed description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Uniphed

Rij Pharmaceutical Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL*)

Pseudoephedrine HCl, USP 15 mg

Purpose

Nasal Decongestant

Childrens Uniphed 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 age ask a doctor
children 2 to under 6 years of age one (1) teaspoonful
children 6 to under 12 years of age two (2) teaspoonfuls
adults and children 12 years of age and over four (4) teaspoonfuls

Childrens Uniphed 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

Childrens Uniphed

Pseudoephedrine hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53807-422
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 15 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53807-422-04 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1999-03-16


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Be sure to consult your doctor before taking any medication!
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