PAIN RELIEF INFANTS (ACETAMINOPHEN) SUSPENSION [P & L DEVELOPMENT, LLC]

PAIN RELIEF INFANTS (ACETAMINOPHEN) SUSPENSION [P & L DEVELOPMENT, LLC]
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NDC 49580-0322-2
Set ID 9f2f2ea1-0fde-462c-ba6c-a5201f814e35
Category HUMAN OTC DRUG LABEL
Packager P & L Development, LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily reduces fever
    • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
  • 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 drug containing acetaminophen (prescription or non prescription). 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

    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days

    These could be signs of a serious condition.

    Keep out of 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 even if you do not notice any signs or symptoms.

  • Directions

    • this product does not contain directions or complete warnings for adult use.
    • do not take more than directed (see overdose warning)
    • shake well before using
    • mL= milliliter
    • only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child
    • remove cap, insert syringe into hole at top of bottle until it snaps into place and turn upside down
    • pull back syringe until filled to be prescribed level. If you pass the prescribed level, invert assembly to right side up on flat surface and simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek)
    • If needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give more than 5 days unless directed by a doctor
    • replace cap tightly to maintain child resistance
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age
    Weight (lb)Age (year)  Dose (mL)
     under 24under 2 ask a doctor
     24-35 2-3 5 mL
  • Other information

    • store between 20-25ºC (68º-77ºF)
    • do not refrigerate.
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    butylparaben, carboxymethylcellulose sodium, citric acid, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purfied water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    Call 1-877-753-3935 MOnday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient in Infants' Tylenol® Oral Suspension**

    Infants' Pain and Fever

    Acetaminophen 160 mg per 5 mL

    oral suspension

    pain reliever / fever reducer

    dye free

    for ages 2-3 years

    alcohol free

    aspirin free

    ibuprofen free

    Cherry flavor

    Use only enclosed syringe

    FL OZ (mL)

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Infants' Tylenol® Oral Suspension.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.

    Manufactured by:

    PL Developments

    11865 S Alameda St

    Lynwood, CA 90262

  • Package Label

    Acetaminophen 160 mg

    ReadyinCase Infants Pain Relief Cherry Liquid

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  INFANTS
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0322
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0322-21 in 1 BOX04/30/2016
    159 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 FINALpart34304/30/2016
    Labeler - P & L Development, LLC (101896231)

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