Label: ACETAMINOPHEN elixir

  • 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 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:

    17856-5401-01 ACETAMINOPHEN - 48MG/1.5ML SYRINGE 120 UD
    17856-5401-02 ACETAMINOPHEN - 64MG/2ML SYRINGE 120 UD
    17856-5401-03 ACETAMINOPHEN - 96MG/3ML SYIRNGE 120 UD
    17856-5401-04 ACETAMINOPHEN - 3.75 ML SYRINGE 48 ct UD
    17856-5401-05 ACETAMINOPHEN - 5 ML CUP 72 ct UD
    17856-5401-06 ACETAMINOPHEN - 192MG/6ML SYRINGE 48 ct UD
    17856-5401-07 ACETAMINOPHEN - 240MG/7.5ML SYRINGE 48 ct UD
    17856-5401-08 ACETAMINOPHEN - 325MG/10.15 ML CUP 72 ct UD
    17856-5401-09 ACETAMINOPHEN - 480MG/15ML 50 CUP 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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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5401(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:17856-5401-1120 in 1 BOX, UNIT-DOSE09/02/2020
    11.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    2NDC:17856-5401-2120 in 1 BOX, UNIT-DOSE09/02/2020
    22 mL in 1 SYRINGE; Type 0: Not a Combination Product
    3NDC:17856-5401-3120 in 1 BOX, UNIT-DOSE09/02/2020
    33 mL in 1 SYRINGE; Type 0: Not a Combination Product
    4NDC:17856-5401-448 in 1 BOX, UNIT-DOSE09/02/2020
    43.75 mL in 1 SYRINGE; Type 0: Not a Combination Product
    5NDC:17856-5401-572 in 1 BOX, UNIT-DOSE09/02/2020
    55 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    6NDC:17856-5401-648 in 1 BOX, UNIT-DOSE09/02/2020
    66 mL in 1 SYRINGE; Type 0: Not a Combination Product
    7NDC:17856-5401-748 in 1 BOX, UNIT-DOSE09/02/2020
    77.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    8NDC:17856-5401-872 in 1 BOX, UNIT-DOSE09/02/2020
    810.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    9NDC:17856-5401-950 in 1 BOX, UNIT-DOSE09/02/2020
    915 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 FINALpart34307/28/2020
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-5401) , repack(17856-5401)
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