Label: CAREONE CHILDRENS ACETAMINOPHEN- acetaminophen suspension
- NDC Code(s): 41520-615-26, 41520-615-28
- Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
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 August 2, 2018
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- Download DRUG LABEL INFO: PDF XML
- 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
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Inactive ingredients
anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
- Questions or comments?
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Principal Display Panel
Compare to the active ingredient in Children’s Tylenol® Oral Suspension
For Ages 2 to 11 Years
Children’s
ACETAMINOPHEN 160mg PER 5mL
Fever Reducer/Pain Reliever
Oral Suspension Liquid
Alcohol Free
Aspirin Free
Ibuprofen Free
Gluten Free
dosage cup included
OUR PHARMACISTS RECOMMEND
Cherry Flavor
4 FL OZ (118mL)
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INGREDIENTS AND APPEARANCE
CAREONE CHILDRENS ACETAMINOPHEN
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-615 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) BUTYLPARABEN (UNII: 3QPI1U3FV8) CALCIUM SULFATE (UNII: WAT0DDB505) CARRAGEENAN (UNII: 5C69YCD2YJ) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X) Product Characteristics Color RED (opaque) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-615-26 1 in 1 CARTON 04/11/2016 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41520-615-28 1 in 1 CARTON 04/11/2016 2 148 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 not final part343 04/11/2016 Labeler - American Sales Company (809183973)