Label: PAIN RELIEVER PLUS- acetaminophen, caffeine tablet

  • 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 April 18, 2022

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

  • ACTIVE INGREDIENT

    Acetaminophen 500mg

    Caffeine 65mg

  • PURPOSE

    Pain reliever/fever reducer

    Pain reliever aid

  • Uses

    temporarily relieves minor aches and pains due to:  

    • headache  
    • muscular aches
  • WARNINGS

    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 tablets 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, occasionally, rapid heartbeat.

    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.

  • DO NOT USE

    Do not use  

    • if you are allergic to acetaminophen  
    • 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.
  • 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 for more 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.

  • Directions

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

    store at 20-25°C (68-77° F)

  • INACTIVE INGREDIENT

    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

  • PRINCIPAL DISPLAY PANEL

    labellabel2

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER PLUS 
    acetaminophen, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73659-014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorbrownScorescore with uneven pieces
    ShapeROUNDSize17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73659-014-0150 in 1 BOX04/18/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:73659-014-02125 in 1 BOX04/18/2022
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/18/2022
    Labeler - Rapid Care, Inc (877432778)