Label: ACETAMINOPHEN elixir

  • Category: HUMAN OTC DRUG LABEL

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 November 14, 2022

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  • Active ingredient (in each 5 mL = 1 teaspoonful)

    Acetaminophen 160 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    To reduce fever and for the temporary relief of minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps.

    Temporarily reduces fever.

  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if

    • adult takes 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
    • adult has 3 or more alcoholic drinks everyday while using this product.

    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
    • is on a sodium-restricted diet.

    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

    Stop use and ask a doctor if:

    • Pain gets worse or lasts more than 5 days
    • 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.

    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 right away. Quick medical
    attention is critical for adults/children even if you do not notice any signs or symptoms.

  • Directions

    • shake well before using
    • find the right dose on chart below, if possible, use weight to dose; otherwise use age
    • dosage may be repeated every 4 hours, or as directed by your doctor
    • do not use more than 5 doses in 24 hours
    • do not use more than 5 days unless directed by a doctor.
    • find right dose on chart below, If possible, use weight to dose; otherwise, use age.
    Weight (lbs.)          Age (years)             dosage-teaspoonful (tsp.)
     under 24 under 2 consult Physician
     24 to 35 2 to 3 1 tsp. (5 mL)
     36 to 47 4 to 5 1 1/2 tsp. (7.5 mL)
     48 to 59 6 to 8 2 tsp. (10 mL)
     60 to 71 9 to 10 2 1/2 tsp. (12.5 mL)
     72 to 95 11 3 tsp. (15 mL)

  • Other information

    • Store at room temperature 15°-30° C (59°-86°F)
    • Protect from Freezing. 
    • Protect from Light.
  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

  • Inactive Ingredients:

    Bubble Gum Flavor, Citric Acid, FD C RED #40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • PRINCIPAL DISPLAY PANEL

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0182(NDC:71399-0160)
    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)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0182-35 in 1 SYRINGE11/03/2022
    1NDC:17856-0182-1120 in 1 BOX, UNIT-DOSE
    1NDC:17856-0182-22 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:17856-0182-472 in 1 BOX, UNIT-DOSE11/14/2022
    2NDC:17856-0182-55 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34305/18/2021
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-0182)
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