Label: CHILDRENS PAIN AND FEVER- acetaminophen 160mg/5ml solution
- NDC Code(s): 73282-0011-1, 73282-0115-4
- Packager: Calmco LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 19, 2023
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- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredient (in each 5mL)
- 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 for this product • 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 is allergic to acetaminophen or any of the inactive ingredients in this product
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Directions
• this product does not contain directions or complete warnings for adult use.
• do not give more than directed (see overdose warning)
• use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age
• give the recommended number of vials below following the instructions under "Easy to Use" on the side panel.
• empty each Single-Use Vial required of all liquid when dosing
• 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
Dosing Chart
Weight (lbs) Age (Years) Dose (mL) under 24 lbs under 2 years Talk to a doctor 24 -35 lbs 2 - 3 years 1 Single-Use Vial (5 mL) 36 - 47 lbs 4-5 years Talk to a doctor 48 - 71 lbs 6-10 years 2 Single-Use Vial (10 mL) 72 - 95 lbs 11 years 3 Single-Use Vial (15 mL) - Other information
- Inactive ingredients
- Questions or Comments?
- Package
- Package - 4ct
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INGREDIENTS AND APPEARANCE
CHILDRENS PAIN AND FEVER
acetaminophen 160mg/5ml solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73282-0011 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 WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MALTITOL (UNII: D65DG142WK) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:73282-0011-1 20 in 1 CARTON 08/06/2021 1 5 mL in 1 VIAL; 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 08/06/2021 CHILDRENS PAIN AND FEVER
acetaminophen 160mg/5ml solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73282-0115 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 WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MALTITOL (UNII: D65DG142WK) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:73282-0115-4 4 in 1 CARTON 01/11/2022 1 5 mL in 1 VIAL; 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 08/06/2021 Labeler - Calmco LLC (079308308)