PediaCare Childrens Plus Cough and Sore Throat

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL, ACETAMINOPHEN 160mg in 5mL
Labeler: Blacksmith Brands, Inc.
NDC Code: 52183-355

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 Childrens Plus Cough and Sore Throat

Drug Facts

Active ingredient

(in each 5 mL, 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Active ingredient

(in each 5 mL, 1 teaspoon)

Dextromethorphan HBr 5 mg

Purpose

Cough Suppressant

Uses
  • temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • cough
  • headache
  • sore throat
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
  • to make child sleepy
  • 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.
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if your child has
  • glaucoma
  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if

your child is taking

  • the blood thinning drug warfarin 

When using this product
  • do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if
  • new symptoms occur
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • pain, nasal congestion or cough gets worse or lasts for more than 5 days
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Keep this and all drugs out of the reach of children.

Overdose Warning: 

Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • do not exceed recommended dosage (see overdose warning)
  • do not use in infants
  • this product does not contain directions or complete warnings for adult use.
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • tsp = teaspoon, mL = milliliter
Weight (lb)Age (yr)Dose (tsp or mL)
under 36under 4do not use
36-474-5do not use unless directed by a doctor
48-956-112 tsps or 10 mL

Other information
  • dosage cup provided
  • store at room temperature

Inactive ingredients

acesulfame potassium, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, purified water, red 33, red 40, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

call 1-888-474-3099

Distributed by:
Blacksmith Brands Inc.
200 White Plains Road
Tarrytown, NY 10591 USA
© 2010

PRINCIPAL DISPLAY PANEL

PediaCare® Children’s Fever Reducer
Pain Reliever Plus Cough & Sore Throat
Luden’s® Cherry Taste!
4 FL OZ (118 mL)

PEDIACARE CHILDRENS PLUS COUGH AND SORE THROAT 
dextromethorphan hydrobromide and acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-355
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CARBOXYMETHYLCELLULOSE SODIUM 
CITRIC ACID 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
WATER 
D&C RED NO. 33 
FD&C RED NO. 40 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52183-355-041 BOTTLE (1 BOTTLE) in 1 BOX
1113 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/09/2010
Labeler - Blacksmith Brands, Inc. (021411299)
Establishment
NameAddressID/FEIOperations
Aaron Industries113044205MANUFACTURE

Revised: 10/2010
 
Blacksmith Brands, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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