Label: 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 September 24, 2018

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient (in each 5mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever - Fever reducer

  • Uses

    Temporarily relieves minor aches and pains due to:

    • the common cold • flu • headache • sore throat • toothache

    Temporarily reduces fever

  • 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 • 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 product 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

    Ask a doctor before use if your child has liver disease

    Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

    When using this product, do not exceed recommended dose (see overdose warning)

    Stop use and ask a doctor if
    • pain gets worse or last for more than 5 days
    • fever gets worse or last for more than 3 days
    • new symptoms occur • redness or swelling is present
    These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.
    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 as well as children even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • find right dose on chart. If possible, use weight to dose; otherwise, use age
    • mL = milliliter
    • if needed, repeat dose every 4 hours
    • do not use more than 5 doses in 24 hours
    • use enclosed dosing cup only. Do not use any other device

    WeightAge Dose
    under 24 lbsUnder 2 yearsask a doctor
    24 to 35 lbs2 to 3 years5mL
    36 to 47 lbs4 to 5 years7.5mL
    48 to 59 lbs6 to 8 years10mL
    60 to 71 lbs9 to 10 years12.5mL
    72 to 95 lbs11 years15mL

  • Inactive ingredients

    artificial flavour, Methylparaben, Propylparaben, Potassium sorbate, Citric Acid Monohydrate, Sorbitol, Propylene glycol, Sucralose, Povidone K30, Glycerin, FD&C Red #40, D&C Red #33 & Purified water.

  • Other information

    • TAMPER EVIDENT: Do not use this product if inner foil seal over mouth of the bottle is cut, torn, broken, or missing.

    • store at 20°- 25°C (68° - 77°F)

    • this product is not the same concentration as Infants' Drops. For accurate dosing, follow the dosing instructions on this label.

  • Questions or Comments?

    1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

  • SPL UNCLASSIFIED SECTION

    Fast, Effective Relief of Children's Fever and Pain

    • Alcohol Free
    • Aspirin Free
    • Cherry Flavor

    DOSAGE CUP ENCLOSED

    ​COMPARE TO the active ingredient of TYLENOL®*LIQUID

    TAMPER EVIDENT

    Child-Resistant Safety Cap Unbreakable Bottle

    * Delsam Pharma Llc is not affiliated with the owner of the registered trademark Tylenol®

    Distributed by

    Delsam Pharma Llc

    Bronx, Newyork 10467

  • Packaging

    Acetaminop-1

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72570-100
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POVIDONE K30 (UNII: U725QWY32X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (pinkish red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72570-100-041 in 1 CARTON09/25/2018
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/25/2018
    Labeler - Delsam Pharma Llc (081369679)