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
  • 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 January 10, 2023

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

  • 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 not finalpart34301/13/2023
    Labeler - Bayer HealthCare LLC. (112117283)