PediaCare Childrens Fever Reducer Pain Reliever Cherry

Manufacturer
Denison Pharmaceuticals, LLC
Effective date
2019-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:31:22

Label at a glance#

ProductPediaCare Childrens Fever Reducer Pain Reliever Cherry
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

  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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL)

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  •   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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-13120295-1312-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d30ac12d-d041-0480-e053-2a95a90a80218151a0c8-611d-bef5-e053-2a91aa0a3a022021-12-13WarningsExact identifier
spl set id: 8151a0c8-611d-bef5-e053-2a91aa0a3a02

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.