Label: BACKAID INFLAMMATORY PAIN FORMULA- acetaminophen, aspirin, caffeine tablet, film coated

  • NDC Code(s): 52389-622-28
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • 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 October 22, 2012

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

  • Active ingredients (in each caplet)

    Acetaminophen, 250 mg

    Aspirin (NSAID)*, 250 mg

    Caffeine Anhydrous, 65 mg

    *Non-steroidal anti-inflammatory drug

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  • Purpose

    Analgesic (pain reliever)

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  • INDICATIONS & USAGE

    Uses For the temporary relief of minor aches and pains including the minor pain of arthritis.
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  • 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
    • asthma (wheezing)
    • shock

    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 products containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product.
    Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (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 (anti-coagulant) 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.
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  • DO NOT USE

    Do not use
    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • 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.
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  • 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 disease, liver cirrhosis or kidney disease
    • you are taking a diuretic
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  • 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.
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  • STOP USE

    Stop use and ask a doctor if
    • an allergic reaction occurs. Seek medical help right away.
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present.
    • ringing in the ears or hearing loss occurs.
    • any new symptoms occur
    • you experience any of the following signs of stomach bleeding:
      • you feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed by a doctor because it may cause problems in the unborn child or complications during delivery.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a poison control center right away.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Close
  • Directions

    • Read all package directions and warnings before use and use only as directed.
    • Adults:  Two (2) caplets every 6 hours while symptoms persist, not to exceed 4 doses (8 caplets) in 24 hours, or as directed by a doctor.
    • Drink a full glass of water with each dose
    • Intended for use by normally healthy adults only
    • Persons under 18 years of age should use only as directed by a doctor.
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  • Other information

    **Contents sealed: Each BACKAID IPF white colored,  capsule shaped caplet bears the identifying mark "ALVA" and a "2" on the reverse side, and is packaged in a bottle with a safety seal under the cap.  Do not use if the seal appears broken or if product contents do not match product description.  You may report serious side effects to the phone number provided under Questions? below.

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  • INACTIVE INGREDIENT

    Inactive ingredients: Hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide and triglycerides.

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  • QUESTIONS

    Questions?  1-800-792-2582

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  • INGREDIENTS AND APPEARANCE
    BACKAID  INFLAMMATORY PAIN FORMULA
    acetaminophen, aspirin, caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-622
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 250 mg
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 65 mg
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    Hypromelloses (UNII: 3NXW29V3WO)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Polydextrose (UNII: VH2XOU12IE)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    stearic acid (UNII: 4ELV7Z65AP)  
    talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    Color white Score no score
    Shape CAPSULE (capsule-shaped caplet) Size 17mm
    Flavor Imprint Code ALVA;2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-622-28 1 in 1 CARTON
    1 28 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 10/22/2012
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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