Label: BAYER RAPID RELIEF- aspirin/caffeine oral powder powder

  • NDC Code(s): 0280-0103-01, 0280-0103-02, 0280-0103-03
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Aspirin 650 mg (NSAID)*

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

    Pain reliever aid

  • Uses

    temporarily relieves minor aches and pains due to: • headache • muscle pain • backache • menstrual cramps • minor pain of arthritis • temporarily reduces feve

  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ● are age 60 or older ● have had stomach ulcers or bleeding problems ● take a blood thinning (anticoagulant) or steroid drug ● take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ● have 3 or more alcoholic drinks every day while using this product ● take more or for a longer time than directed

    Do not use ● if you are allergic to aspirin or any other pain reliever/fever reducer ● if you have ever had an allergic reaction to this product or any of its Ingredients Ask a doctor before use if ● stomach bleeding warning applies to you ● you have a history of stomach problems, such as heartburn ● you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ● you are taking a diuretic ● you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for ● gout ● diabetes ● arthritis Stop use and ask a doctor if ● an allergic reaction occurs. Seek medical help right away. ● you experience any of the following signs of stomach bleeding: ● feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better ● pain gets worse or lasts more than 10 days ● fever gets worse or lasts more than 3 days ● redness or swelling is present ● new symptoms occur ● ringing in the ears or a loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years and over: take contents of 1 powder pack every 6 hours. Dissolve powder on tongue, followed by a full glass of water. Do not exceed 4 powder packs in 24 hours. ● children under 12 years: consult a doctor

  • Other information

    ● phenylketonurics: contains phenylalanine 0.0017 mg per powder pack ● save carton for full directions and warnings ● Store between 20°- 25 °C (68°-77° F)

  • Inactive Ingredients

    anhydrous citric acid, flavors, mannitol, neotame, sodium citrate monobasic, sucralose

  • Questions or comments?

    1-800-331-4536 (Mon-Fri 9AM - 5PMEST)

  • KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    ASPIRIN_RapidReliefPowder

  • INGREDIENTS AND APPEARANCE
    BAYER RAPID RELIEF 
    aspirin/caffeine oral powder powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0103
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MANNITOL (UNII: 3OWL53L36A)  
    NEOTAME (UNII: VJ597D52EX)  
    MONOSODIUM CITRATE (UNII: 68538UP9SE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0103-011 in 1 CARTON01/13/2023
    110 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0280-0103-021 in 1 CARTON01/13/2023
    220 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0280-0103-031 in 1 CARTON01/13/2023
    330 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/13/2023
    Labeler - Bayer HealthCare LLC. (112117283)