Label: ACETAMINOPHEN liquid
- NDC Code(s): 83720-500-16
- Packager: Oncor Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 15, 2024
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- 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 containing acetaminophen
Allergy alert:Acetaminophen may cause severe skin reactions.
Symptoms may include:
• skin reddening • blisters • rashIf 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.
Ask a doctor before useif your child has liver disease.
Ask a doctor or pharmacist before useif your child is taking the blood thinning drug warfarin.
Stop use and ask a doctor if• pain gets worse or lasts more than 5 days
- pain gets worse or lasts more than 5 day.
- fever gets worse or lasts more than 3 days
- redness or swelling is present.
- any new symotom appear.
These could be signs of a serious condition.
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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.
Weight (lbs.)
Age (years) Dosage Teaspoonful (tsp)* Under 24 Under 2 Consult a doctor 24 to 35 2 to under 4 5 mL (1 tsp) 36 to 47 4 to under 6 7.5 mL (1 1/2 tsp) 48 to 59 6 to under 9 10 mL (2 tsp) 60 to 71 9 to under 11 12.5 mL (2 1/2 tsp) 72 to 95 11 to under 12 15 mL (3 tsp) * or as directed by a doctor
- Other information
- Inactive ingredients
- Questions?
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83720-500 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) 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:83720-500-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/10/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 04/10/2024 Labeler - Oncor Pharmaceuticals (119032580) Registrant - Oncor Pharmaceuticals (119032580)
