Label: EXTRA PAIN RELIEF- acetaminophen, aspirin and caffeine tablet, film coated

  • NDC Code(s): 49483-370-00, 49483-370-01, 49483-370-20, 49483-370-42
  • Packager: TIME CAP LABS
  • 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 July 15, 2021

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)
    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID)*
    Caffeine 65 mg
    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose
    Pain reliever
    Pain reliever aid

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor aches and pains due to:

    headache
    a cold
    arthritis
    muscular aches
    toothache
    premenstrual and menstrual cramps

  • WARNINGS

    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
    • shock
    • asthma (wheezing)

    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

    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

    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.

  • DO NOT USE

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
  • ASK DOCTOR

    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
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drug or are under a doctor’s care for any serious condition
  • STOP USE

    Stop using and ask a doctor if

    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse
    • you experience any of the following signs of stomach bleeding:

    feel faint
    have bloody or black stools
    vomit blood
    have stomach pain that does not get better
    ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of 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

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

  • DIRECTIOINS

    Directions

    • do not use more than directed
    • drink a full glass of water with each dose
    • 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

    Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide

  • QUESTIONS

    Questions or comments? call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    24ct carton

    24ct label

    200ct label

    100ct carton

    100ct label

  • INGREDIENTS AND APPEARANCE
    EXTRA PAIN RELIEF 
    acetaminophen, aspirin and caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-370
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE ((CAPSULE SHAPED TABLET)) Size18mm
    FlavorImprint Code TCL370
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-370-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/16/2021
    2NDC:49483-370-20200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2013
    3NDC:49483-370-0020000 in 1 CARTON; Type 0: Not a Combination Product02/22/2016
    4NDC:49483-370-421 in 1 CARTON07/16/2021
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/01/2013
    Labeler - TIME CAP LABS (037052099)
    Registrant - TIME CAP LABS (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABS037052099manufacture(49483-370)