DailyMed - APAP ELIXER (ACETAMINOPHEN) (2024)

  • Label RSS
  • Contains inactivated NDC Code(s)
    NDC Code(s):
    54162-129-16
  • Packager: GERITREX LLC
  • 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 19, 2018

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

  • Download DRUG LABEL INFO: PDF XML
  • Official Label (Printer Friendly)

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

    Acetaminophen 160 mg

  • Purpose
  • 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.
    Weight (lbs.) Age (years) dosage-teaspoonful (tsp.)
    under 24under 2consult Physician
    24-352 to 31 tsp. (5 mL)
    36-474 to 51 1/2 tsp. (7.5 mL)
    48-596 to 82 tsp. (10 mL)
    60-719 to 102 1/2 tsp. (12.5 mL)
    72-9511 to 123 tsp. (15 mL)
    over 9512 to adult4 tsp. (20 mL)
  • Other information
    • Store at room temperature 15º-30ºC (59º-86ºF)
    • protect from freezing
    • protect from light
    • each teaspoon (5mL) contains: sodium 7 mg
  • SPL UNCLASSIFIED SECTION

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

  • Inactive Ingredients:

    citric acid, FD&C red #40, glycerin, PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water, art. cherry flavor

  • PRINCIPAL DISPLAY PANEL

    DailyMed - APAP ELIXER (ACETAMINOPHEN) (2)

  • INGREDIENTS AND APPEARANCE
    APAP ELIXER (ACETAMINOPHEN)
    acetaminophen elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160mg in5mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
    FD&C RED NO. 40 (UNII: WZB9127XOA)
    GLYCERIN (UNII: PDC6A3C0OX)
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
    SODIUM BENZOATE (UNII: OJ245FE5EU)
    SODIUM CITRATE (UNII: 1Q73Q2JULR)
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)
    SORBITOL (UNII: 506T60A25R)
    WATER (UNII: 059QF0KO0R)
    Product Characteristics
    ColorREDScore
    ShapeSize
    FlavorCHERRY (CHERRY) Imprint Code
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-129-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34308/20/2018

    Labeler -GERITREX LLC(112796248)

    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX LLC112796248manufacture(54162-129)

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More Info on this Drug

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APAP ELIXER (ACETAMINOPHEN)- acetaminophen elixir

Number of versions: 1

Published Date (What is this?) Version Files
Sep 19, 2018 2 (current) download

RxNorm

APAP ELIXER (ACETAMINOPHEN)- acetaminophen elixir

RxCUI RxNorm NAME RxTTY
1 307675 acetaminophen 160 MG in 5 mL Oral Solution PSN
2 307675 acetaminophen 32 MG/ML Oral Solution SCD
3 307675 acetaminophen 160 MG per 5 ML Oral Solution SY
4 307675 acetaminophen 325 MG per 10.15 ML Oral Solution SY
5 307675 acetaminophen 650 MG per 20.3 ML Oral Solution SY
6 307675 acetaminophen 80 MG per 2.5 ML Oral Solution SY
7 307675 APAP 32 MG/ML Oral Solution SY

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NDC Codes

APAP ELIXER (ACETAMINOPHEN)- acetaminophen elixir

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

NDC
1 54162-129-16 (inactivated)
DailyMed - APAP ELIXER (ACETAMINOPHEN) (2024)
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