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

Principal Display Panel

CHILDRENS UNIPHED NASAL DECONGESTANT
pseudoephedrine hydrochloride liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Rij Pharmaceutical Corporation (144679156)

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