DIACARE CHILDRENS DECONGESTANT- phenylephrine hcl liquid 
Prestige Brands Holdings, Inc.

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.

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PediaCare Childrens Decongestant

PediaCare Children’s Decongestant

Drug Facts

Active ingredient (in each 5 mL)*

Phenylephrine HCl 2.5 mg

Purpose

Nasal decongestant

*5 mL = one teaspoon

Use

 temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Warnings

Do not use

  • in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use

if your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a sodium-restricted diet

When using this product

do not exceed recommended dose

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever

Keep out of reach of children 

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • find right dose on chart below
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours
  • do not give more than 6 times in 24 hours 
 Age Does (tsp)
 Under 4 years Do not use
 4 to 5 years 1 teaspoonful (5 mL)
 6 to 11 years  2 teaspoonfuls (10 mL)

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

  • each teaspoon contains: sodium 14 mg
  • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.
  • do not use if bottle wrap, or foil inner seal imprinted “Safety Seal®” is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, edetate disodium, FD&C red #40, flavors, glycerin, sodium benzoate, sodium citrate, sorbitol, sucralose, water

Questions or comments?

call 1-888-474-3099

PRINCIPAL DISPLAY PANEL

See New Directions
PediaCare
Children’s

Decongestant

Phenylephrine HCI oral solution
4 FL OZ (118
mL)

PRINCIPAL DISPLAY PANEL PediaCare Children’s Decongestant 4 FL OZ (118 mL)
DIACARE CHILDRENS DECONGESTANT 
phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-379
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-379-041 in 1 CARTON10/29/200908/31/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/29/200908/31/2017
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
NameAddressID/FEIBusiness Operations
Trillium Healthcare Products, Inc.255426306MANUFACTURE(52183-379)

Revised: 7/2010
 
Prestige Brands Holdings, Inc.