Label: AEROTAB PAIN RELIEVER- pain reliever tablet

  • NDC Code(s): 55305-127-01, 55305-127-02, 55305-127-04, 55305-127-05
  • 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 March 6, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients (per tablet)

    Acetaminophen 500mg

    Caffeine 65mg

  • PURPOSE

    Acetaminophen 500mg.............Pain Reliever / Fever Reducer

    Caffeine 65mg...........................Pain Reliever Aid

  • USES

    Temporarily relieves minor aches and pains due to:

    • headaches
    • muscular aches
  • WARNINGS

    Allergy Alert: 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.

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 caplets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionaly, rapid heartbeat.

  • DO NOT USE

    Do not use

    • if you are allergic to ascetaminophen
    • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure wheter 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

    • ​any new symptoms occur
    • painful area is red or swollen
    • pain gets worse or lasts form ore than 10 days
    • fever gets worse or lasts for more than 3 days.

    These could be signs of a serious condition.

  • 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 overdose, get medical help or contact a 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

    • do not use more than directed
    • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
    • children under 12 years: ask a doctor
  • Other Information

    • Store at 20-25 C (68-77 F)
    • do not use of pouch is torn or open
  • Inactive Ingredients

    corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.

  • Questions or comments?

    Call 1-845-618-7037

  • PRINCIPAL DISPLAY PANEL

    AEROTAB

    Pain Reliever

    fever reducer

    Acetaminophen 500mg

    Caffeine 65mg

    Extra Strength

    Relieves aches and pains

    Fever reducer

    2 per packet

    25010050Pouch

  • INGREDIENTS AND APPEARANCE
    AEROTAB PAIN RELIEVER 
    pain reliever tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeCAPSULESize17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55305-127-0225 in 1 BOX11/01/2022
    1NDC:55305-127-012 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:55305-127-0450 in 1 BOX11/01/2022
    2NDC:55305-127-012 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:55305-127-05125 in 1 BOX11/01/2022
    3NDC:55305-127-012 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/01/2022
    Labeler - Aero Healthcare (008186174)
    Registrant - Aero Healthcare (008186174)
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