Label: LIQUID ACETAMINOPHEN- acetaminophen liquid

  • 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

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  • Drug Facts

  • Active ingredient (in each 5 mL tsp)

    Acetaminophen, 160 mg

  • Purpose

    Pain reliever/Fever reducer

  • Uses:

    Temporarily relieves of minor aches and pains due to • headache • backache • muscular aches • minor pain of arthritis • the common cold • toothache • premenestrual and menstrual cramps

    Temporarily reduces fever.

  • 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.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

  • 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

    • Store at controlled room tempearature 15°-30°C (59°-86°F). Do not refrigerate. 

    • Protect from light. Avoid excessive heat or humidity.

  • Inactive ingredients

    Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, sucralose

  • Questions or comments?

    Call weekdays from 8 AM to 4 PM AST at 787-767-2072.

    Manufactured in the USA for Kramer Novis, San Juan, PR 00917

  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    LIQUID ACETAMINOPHEN 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-663
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-663-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/02/2020
    Labeler - KRAMER NOVIS (090158395)
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