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PediaCare Childrens Fever Reducer Pain Reliever Cherry

Dosage form: liquid
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Strides Pharma Inc
NDC Code: 59556-854

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 Fever Reducer Cherry

Drug Facts

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily reduces fever
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  •   skin reddening
  •   blisters
  •   rash

If a skin reaction occurs, stop use and seek medical help right away.

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
  •   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
  •   if the child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the child has liver disease.

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.

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

Stop use and ask a doctor if
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  •   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 determine dose; otherwise, use age.
  •   only use the enclosed syringe Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
  •   remove cap and insert syringe into hole at top of bottle and turn upside down.
  •   pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back in until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek).
  •   if needed, repeat dose every 4 hours while symptoms last
  •   do not use more than 5 times in 24 hours (see overdose warning)
  •   do not give more than 5 days unless directed by a doctor
  •   replace cap tightly to maintain child resistance
  •   ml = millilitre
Weight (lbs)
Age (yrs)
Dose (mL)
                  under 24
              under 2 years
  ask a doctor
     24-35
      2-3 years
5 ml

Other Information
  •   store at 20-25˚C (68-77˚F)
  •   tamper evident: do not use if printed seal on bottle is broken or missing

Inactive Ingredients

citric acid , FD&C red no.40, flavors, glycerine, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum

Questions

1-888-474-3099 Monday – Friday 8 am – 5 pm eastern standard time   PediCare.com

Principal Display Panel

Infants  2-3 Years

PediaCare®

Fever REDUCER

Pain RELIEVER

ACETAMINOPHEN

Acetaminophen Oral Suspension 160mg/5ml

Cherry Flavor

2 FL OZ (59 mL)

PEDIACARE CHILDRENS FEVER REDUCER PAIN RELIEVER CHERRY 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-854
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
MICROCRYSTALLINE CELLULOSE 
POTASSIUM SORBATE 
SORBITOL 
SUCRALOSE 
WATER 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59556-854-6059 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/08/2010
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIOperations
Denison Pharmaceuticals, LLC001207208MANUFACTURE(59556-854)

Revised: 07/2017
 
Strides Pharma 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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