Label: CHILDRENS ACETAMINOPHEN- acetaminophen suspension
- NDC Code(s): 68094-586-58
- Packager: Precision Dose Inc.
- This is a repackaged label.
- Source NDC Code(s): 0113-0212
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 17, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
- 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child has ever had an allergic reaction to this product or any of its ingredients
When using this product do not exceed recommended dose (see overdose warning)
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Directions
- use as directed per healthcare professional
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see overdose warning)
- shake cups well before using
- mL = milliliter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- Other information
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Inactive ingredients
anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
- SPL UNCLASSIFIED SECTION
- How Supplied
- SPL UNCLASSIFIED SECTION
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 2.5 mL Syringe Label
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INGREDIENTS AND APPEARANCE
CHILDRENS ACETAMINOPHEN
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-586(NDC:0113-0212) 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, UNSPECIFIED FORM (UNII: WAT0DDB505) carrageenan (UNII: 5C69YCD2YJ) D&C red NO. 33 (UNII: 9DBA0SBB0L) FD&C blue NO. 1 (UNII: H3R47K3TBD) glycerin (UNII: PDC6A3C0OX) high fructose corn syrup (UNII: XY6UN3QB6S) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sodium phosphate, tribasic (UNII: A752Q30A6X) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68094-586-58 50 in 1 CASE 07/30/2014 05/31/2024 1 1 in 1 BAG 1 2.5 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M013 07/30/2014 05/31/2024 Labeler - Precision Dose Inc. (035886746)