PEDIACARE CHILDRENS FEVER REDUCER PAIN RELIEVER CHERRY- acetaminophen liquid

PediaCare Childrens Fever Reducer Pain Reliever Cherry by

Drug Labeling and Warnings

PediaCare Childrens Fever Reducer Pain Reliever Cherry by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

PEDIACARE CHILDRENS FEVER REDUCER PAIN RELIEVER CHERRY 
acetaminophen liquid

Product 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)