PEDIACARE LONGACTING COUGH- dextromethorphan hbr 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.

----------

PediaCare Long-Acting Cough

PediaCare Children’s Long-Acting Cough

Drug Facts

Active ingredient (in each 5 mL)*

Dextromethorphan HBr 7.5 mg

Purpose

Cough suppressant

*5 mL = one teaspoon

Use

temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

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 the child has

  • persistent or chronic cough such as occurs with asthma
  • cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

  • cough gets worse or lasts more than 7 days
  • cough tends to come back or occurs with fever, rash, or headache that lasts

These could be signs of a serious condition.

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.
  • if needed, repeat dose every 6 to 8 hours
  • do not use more than 4 times in 24 hours

Do not use any other dosing device.

 Age (yr) Does (tsp)
 Under 4 years Do not use
 4 to 5 years one (1) teaspoonful
 6 to 11 years  two (2) teaspoonfuls

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

Other information

  • each teaspoon contains: sodium 15 mg
  • store between 20-25°C (68-77°F). 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

anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

Questions or comments?

call 1-888-474-3099

Principal Display Panel

See New Directions
PediaCare
Children’s
Long-Acting Cough
Dextromethorphan HBr oral solution
Grape
Flavor Liquid
4 FL OZ (118 mL)

Principal Display Panel PediaCare Children’s Long-Acting Cough 4 FL OZ (118 mL)
PEDIACARE LONGACTING COUGH 
dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-369
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-369-041 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)

Revised: 7/2010
Document Id: e0a97b0d-9963-46cd-9df5-6ae8bce6af5b
Set id: 8e97133f-3ffc-4882-b545-0e60d06c4a10
Version: 4
Effective Time: 20100703
 
Prestige Brands Holdings, Inc.