Label: FRIDABABY CHILDREN PAIN AND FEVER ACETAMINOPHEN 160MG PER 5ML VIAL 10CT- acetaminophen 160mg per 5ml solution
- NDC Code(s): 72705-124-10
- Packager: Fridababy LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 19, 2023
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- Official Label (Printer Friendly)
- Active Ingredient (in each 5mL)
- 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 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, persistent 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.
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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 dose, otherwise, use age.
■ give the recommended number of vials below. To open, follow the instructions under How to Use.
■ 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
Weight (lbs) Age (Years) Dose under 24 lbs. under 2 years Ask a doctor 24-35 lbs. 2 - 3 years 1 Single Use Vial (5 mL)
36-47 lbs. 4-5 years Ask 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 Ingredient
- Questions or Comments?
- Package
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INGREDIENTS AND APPEARANCE
FRIDABABY CHILDREN PAIN AND FEVER ACETAMINOPHEN 160MG PER 5ML VIAL 10CT
acetaminophen 160mg per 5ml solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72705-124 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 MALTITOL (UNII: D65DG142WK) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM METABISULFITE (UNII: 4VON5FNS3C) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72705-124-10 10 in 1 POUCH 08/16/2022 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 08/16/2022 08/31/2024 Labeler - Fridababy LLC (783729598)