Label: ACETAMINOPHEN liquid
- NDC Code(s): 69367-323-04, 69367-323-16
- Packager: Westminster Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 4, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
- 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 that contain 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.
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Directions
- this product does not contain directions or complete warnings for adult use
- use only the enclosed dosing cup designed for use with this product
- if possible, use weight to dose, otherwise use age
- dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69367-323 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69367-323-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/05/2021 2 NDC:69367-323-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M013 05/05/2021 Labeler - Westminster Pharmaceuticals, LLC (079516651)