Label: AEROTAB NON-ASPIRIN- acetaminophen 500mg es tablet

  • NDC Code(s): 55305-126-01, 55305-126-02, 55305-126-04, 55305-126-05
  • Packager: Aero Healthcare
  • 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 May 1, 2023

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  • ACTIVE INGREDIENT

    Acteminophen 500 mg

  • PURPOSE

    Pain reliever / fever reducer

  • USES

    temporary relief of minor aches and pains associated with

    • common cold
    • headache
    • toothache
    • muscular aches
    • backache
    • arthritis
    • menstrual cramps
    • temporarily reduces fever
  • WARNINGS

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if

    • adult takes more than 4000 mg of acetaminophen in 24 hours
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    Allergy Warning: 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.

  • DO NOT USE

    Do not use

    • if you are allergic to acetaminophen
    • with any other drug containing acetaminophen (prescription or nonprescription).

    If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • ASK DOCTOR

    Ask a doctor before use if you have liver disease.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

  • STOP USE

    Stop use and ask a doctor if

    • symptoms do not improve
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • new symptoms occur
    • redness or swelling is present
    • a rare sensitivity reaction occurs
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DIRECTIONS

    • take only as directed - see Overdose warning
    • do not take more than 8 tablets in any 24 hour period
    • do not use more than 10 days unless directed to do so by a doctor

    Adults and children 12 years and over: take 2 tablets every 4 to 6 hours.

    Children under 12 years of age: do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

  • OTHER INFORMATION

    Tamper evident. Do not use if packet is torn, cut or opened. Store between 20°-25°C (68°-77°F). Read all warnings and directions before use.

  • INACTIVE INGREDIENTS

    corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • PRINCIPAL DISPLAY PANEL

    AEROTAB

    Non-Aspirin

    acetaminophen 500mg

    Fever reducer

    Pain Reliever

    Relieves aches

    2 per packet

    25010050pouch

  • INGREDIENTS AND APPEARANCE
    AEROTAB NON-ASPIRIN 
    acetaminophen 500mg es tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-126
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55305-126-0225 in 1 BOX10/31/2017
    1NDC:55305-126-012 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:55305-126-0450 in 1 BOX10/31/2017
    2NDC:55305-126-012 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:55305-126-05125 in 1 BOX10/31/2017
    3NDC:55305-126-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/31/2017
    Labeler - Aero Healthcare (008186174)
    Registrant - Aero Healthcare (008186174)
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