Label: LIQUID ACETAMINOPHEN- acetaminophen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 52083-663-16 - Packager: KRAMER NOVIS
- 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 March 2, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each 5 mL tsp)
- Purpose
- Uses:
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Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
• adults take more than 6 doses in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen (prescription or nonprescription)
• adults has 3 or more alcoholic drinks while using this product
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
Do not use with any other product containing acetaminophen (prescription or nonprescription), this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
WHEN USING THIS PRODUCT, DO NOT EXCEED RECOMMENDED DOSE
Ask a doctor before use if you have a liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if • pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• fever gets worse or lasts more than 3 days • new symptoms occur
• redness or swelling is present. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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Directions
Dosage may be repeated every 4 hours, or as directed by doctor.
Do not exceed recommended dose.
Find dose in chart below. If possible, use weight to dose, otherwise use age.
Weight (lbs)
Under 24 24-35 36-47 48-59 60-71 72-95 Over 95 Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult Dosage teaspoonful
(tsp)
consult a doctor 1 tsp (5 mL)
1 1/2 tsp
(7.5 mL)2 tsp
(10 mL)2 1/2 tsp
(12.5 mL)3 tsp
(15 mL)4 tsp
(20 mL) - Other information
- Inactive ingredients
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Compare to the active ingredient of Tylenol® Liquid*
√ Alcohol Free
√ Aspirin Free
Cherry Flavor
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Liquid.
TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.
www.kramernovis.com
- Packaging
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INGREDIENTS AND APPEARANCE
LIQUID ACETAMINOPHEN
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-663 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) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-663-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/02/2020 Labeler - KRAMER NOVIS (090158395)