Label: ACETAMINOPHEN elixir

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 2, 2020

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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.

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

  • Inactive Ingredients:

    Grape Flavor, Citric Acid, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

    How Supplied:

    17856-5402-01 ACETAMINOPHEN 2.5 ML ENFIT SYRINGE 120 ct UD
    17856-5402-02 ACETAMINOPHEN 2 ML ENFIT SYRINGE 120 ct UD
    17856-5402-03 ACETAMINOPHEN 3.8 ML ENFIT SYRINGE 48 ct UD
    17856-5402-04 ACETAMINOPHEN 15 ML CUP 72 ct UD
    17856-5402-05 ACETAMINOPHEN 20.31 ML CUP 50 ct UD
    17856-5402-06 ACETAMINOPHEN 6.25 ML ENFIT SYRINGE 48 ct UD
    17856-5402-07 ACETAMINOPHEN 7.5 ML ENFIT SYRINGE 48 ct UD
    17856-5402-08 ACETAMINOPHEN 31.2 ML CUP 50 ct UD
    17856-5402-09 ACETAMINOPHEN  5 ML SYRINGE 48 ct UD

  • Questions or Comments?

    Call (877) 225-6999 Monday - Friday 9AM-5PM EST

    Manufactured for
    Akron Pharma, Inc.,
    Fairfeld, NJ - 07004

    Manufactured In USA

    * This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179   

  • Principal Display Panel

    • Compare To Active ingredient of Children's Tylenol Elixir

    Children's

    Pain Relief

    Pain Reliever and
    Fever Reducer

    Acetaminophen 160 mg per 5 ml Oral Elixir

    • Alcohol Free

    • Asprin Free

    • For Ages 2 - 11 years

    Grape Flavor

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    image 3image 4

    image 5image 6

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5402(NDC:71399-0161)
    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
    GRAPE (UNII: 6X543N684K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-5402-1120 in 1 BOX, UNIT-DOSE09/02/2020
    12.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    2NDC:17856-5402-2120 in 1 BOX, UNIT-DOSE09/02/2020
    22 mL in 1 SYRINGE; Type 0: Not a Combination Product
    3NDC:17856-5402-348 in 1 BOX, UNIT-DOSE09/02/2020
    33.8 mL in 1 SYRINGE; Type 0: Not a Combination Product
    4NDC:17856-5402-472 in 1 BOX, UNIT-DOSE09/02/2020
    415 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    5NDC:17856-5402-550 in 1 BOX, UNIT-DOSE09/02/2020
    520.31 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    6NDC:17856-5402-648 in 1 BOX, UNIT-DOSE09/02/2020
    66.25 mL in 1 SYRINGE; Type 0: Not a Combination Product
    7NDC:17856-5402-748 in 1 BOX, UNIT-DOSE09/02/2020
    77.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    8NDC:17856-5402-850 in 1 BOX, UNIT-DOSE09/02/2020
    831.2 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    9NDC:17856-5402-948 in 1 BOX, UNIT-DOSE09/02/2020
    95 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34307/28/2020
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-5402) , repack(17856-5402)
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