Label: PEDIACARE CHILDRENS FEVER REDUCER PAIN RELIEVER CHERRY- acetaminophen liquid
- NDC Code(s): 59556-854-60
- Packager: Strides Pharma Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 24, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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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)
- Keep out of reach of children
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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
- Inactive Ingredients
- Questions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PEDIACARE CHILDRENS FEVER REDUCER PAIN RELIEVER CHERRY
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59556-854 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59556-854-60 59 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 07/08/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/08/2010 Labeler - Strides Pharma Inc (078868278) Establishment Name Address ID/FEI Business Operations Denison Pharmaceuticals, LLC 001207208 MANUFACTURE(59556-854)
