Label: CHILDRENS PAIN AND FEVER- acetaminophen solution
- NDC Code(s): 73282-1164-2
- Packager: CalmCo LLC
- This is a repackaged label.
- Source NDC Code(s): 70302-130
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 July 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each 5ml)
- Purpose
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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.Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.
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 -
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 - Other Information
- Inactive Ingredients
- Questions or Comments?
- Package Art File- 4ct Carton
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INGREDIENTS AND APPEARANCE
CHILDRENS PAIN AND FEVER
acetaminophen solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73282-1164(NDC:70302-130) 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 SODIUM METABISULFITE (UNII: 4VON5FNS3C) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MALTITOL (UNII: D65DG142WK) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SUCRALOSE (UNII: 96K6UQ3ZD4) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73282-1164-2 4 in 1 CARTON 02/01/2022 1 5 mL in 1 VIAL, SINGLE-DOSE; 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 not final part343 02/01/2022 Labeler - CalmCo LLC (079308308) Registrant - CalmCo LLC (079308308)
