leader childrens pain reliever

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Cardinal Health
NDC Code: 37205-518

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.

Cardinal Health Children's Pain Reliever Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

Warnings

Liver warning: This product contains acetaminophen. Severe 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

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if your child has

liver disease

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin

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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • do not give more than directed (see Liver warning)
  • shake well before using
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • this product does not contain directions or complete warnings for adult use
Weight(lb) Age(yr)Dose (tsp or mL)
under 24under 2 yearsask a doctor
24-352–3 years1 tsp or 5 mL
36–474–5 years1 1/2 tsp or 7.5 mL
48–596–8 years2 tsp or 10 mL
60-71 9–10 years2 1/2 tsp or 12.5 mL
72-9511 years3 tsp or 15 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information
  • each teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)
  • do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions or comments?

1-800-719-9260

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Compare to Children’s Tylenol® Oral Suspension active ingredient

For Ages 2 - 11

Children’s

Pain Reliever

Suspension Liquid

Acetaminophen Oral Suspension

80 mg per 1/2 teaspoon (160 mg per 5 mL)

Pain Reliever

Fever Reducer

Grape Flavor

Alcohol Free

Children's Pain Reliever Carton Image 1

Children's Pain Reliever Carton Image 2

LEADER CHILDRENS PAIN RELIEVER 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-518
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
CARRAGEENAN 
D&C RED NO. 33 
FD&C BLUE NO. 1 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
ColorPURPLE (viscous) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-518-261 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/15/1990
Labeler - Cardinal Health (097537435)

Revised: 09/2009
 
Cardinal Health

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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