Label: LEADER CHILDRENS PAIN AND FEVER- acetaminophen suspension
- NDC Code(s): 70000-0481-1
- Packager: Cardinal Health 110, LLC. dba Leader
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 25, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
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- more than 5 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if your child has ever had an allergic reaction to this product or any of its ingredients
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Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed (see overdose warning)
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- shake well before using
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- mL = milliliter
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- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
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- remove the child protective cap and squeeze your child’s dose into the dosing cup
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- repeat dose every 4 hours while symptoms last
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- do not give more than 5 times in 24 hours
Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL
36-47
4-5 years
7.5 mL
48-59
6-8 years
10 mL
60-71
9-10 years
12.5 mL
72-95
11 years
15 mL
- *or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
LEADER™
DYE-FREE
Children’s Pain & Fever
Acetaminophen 160 mg per 5 mL
Oral Suspension
Pain Reliever
Fever Reducer
Cherry Flavor
Ages 2 to 11 Years
COMPARE TO CHILDREN’S TYLENOL® ORAL SUSPENSION active ingredient
Alcohol – Free
Aspirin – Free
Ibuprofen – Free
No Parabens
100% Money Back Guarantee
4 FL OZ (118mL)
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INGREDIENTS AND APPEARANCE
LEADER CHILDRENS PAIN AND FEVER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0481 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505) CARRAGEENAN (UNII: 5C69YCD2YJ) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X) Product Characteristics Color WHITE (opaque,viscous) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0481-1 1 in 1 CARTON 02/25/2019 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/25/2019 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)
