CHILDRENS UNIPHED NASAL DECONGESTANT- pseudoephedrine hydrochloride liquid

Childrens Uniphed by

Drug Labeling and Warnings

Childrens Uniphed by is a Otc medication manufactured, distributed, or labeled by Rij Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL*1)

Pseudoephedrine HCl, USP 15 mg

1 * 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 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

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

INGREDIENTS AND APPEARANCE

CHILDRENS UNIPHED   NASAL DECONGESTANT
pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53807-422
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pseudoephedrine hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)	Pseudoephedrine hydrochloride	15 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
edetate disodium (UNII: 7FLD91C86K)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C red no. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
poloxamer 407 (UNII: TUF2IVW3M2)
polyethylene glycols (UNII: 3WJQ0SDW1A)
povidone K90 (UNII: RDH86HJV5Z)
water (UNII: 059QF0KO0R)
saccharin sodium (UNII: SB8ZUX40TY)
sodium benzoate (UNII: OJ245FE5EU)
sodium citrate (UNII: 1Q73Q2JULR)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53807-422-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/16/1999

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/16/1999

Labeler - Rij Pharmaceutical Corporation (144679156)

Establishment
Name	Address	ID/FEI	Business Operations
Rij Pharmaceutical Corporation		144679156	manufacture(53807-422)