RAPID COMFORT ASPIRIN (ASPIRIN) TABLET, FILM COATED [LAB SAFETY SUPPLY, INC.]

RAPID COMFORT ASPIRIN (ASPIRIN) TABLET, FILM COATED [LAB SAFETY SUPPLY, INC.]
PDF | XML

NDC 60683-106-13, 60683-106-33
Set ID c6649dc5-7903-429f-b63c-6d69002d1990
Category HUMAN OTC DRUG LABEL
Packager Lab Safety Supply, Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Aspirin (NSAID*) 325 mg

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer

  • Uses

    Temporarily relieves minor aches and pains associated with

    • headache
    • minor arthritis pain
    • common cold
    • menstrual cramps
    • muscular aches
    • backache
    • toothache

    Temporarily reduces fever.

  • 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
    • skin reddening
    • facial swelling
    • rash
    • asthma (wheezing)
    • blisters
    • shock

    If an allergic reaction occurs, stop use and seek medical help right away.

    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 alcohol drinks every day while using this product
    • take more or for a longer time than directed

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
    • right before or after heart surgery
    • if you are taking prescription drugs for gout, diabetes or arthritis

    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

    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    • 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
    • you have difficulty swallowing
    • if ringing in the ears or loss of hearing occurs
    • redness or swelling is present in the painful area
    • any new symptoms appear

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

  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)
    • drink a full glass of water with each dose

    Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

    Children under 12 years: Do not give to children under 12 years of age.

  • Other information

    • read all product information before using
    • store at room temperature 59º-86ºF (15º-30ºC)
    • avoid excessive heat and humidity
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • Inactive ingredients

    corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

  • Questions or comments? 1-800-356-0783

  • PRINCIPAL DISPLAY PANEL

    116R LSS -Aspirin 325 mg Label

    Rapid Comfort TM

    ASPIRIN

    5 grain (325 mg) (NSAID)

    Easy to Swallow

    Film-Coated Tablets

    Pull to Open

    Compare active ingredients to:

    Bayer®

    Registered Trademark of Bayer Consumer

    100 Tablets (50x2s)

    Tamer-Evident Unit Dose Packets

    116R LSS -Aspirin 325 mg Label
  • INGREDIENTS AND APPEARANCE
    RAPID COMFORT ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60683-106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code TCL;011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60683-106-13250 in 1 BOX, UNIT-DOSE
    12 in 1 PACKET
    2NDC:60683-106-3350 in 1 BOX, UNIT-DOSE
    22 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34310/14/2011
    Labeler - Lab Safety Supply, Inc. (042851410)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Labs, Inc.037052099MANUFACTURE

Related Drugs