Label: BACKAID MAX- acetaminophen and pamabrom tablet, film coated

  • NDC Code(s): 52389-153-01, 52389-153-02, 52389-153-03, 52389-153-08, view more
    52389-153-28, 52389-153-38
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/10

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

  • Active ingredients (in each pill)

    Acetaminophen, 500 mg

    Pamabrom, 25 mg

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  • Purpose

    Analgesic (pain reliever)

    Diuretic

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  • Uses

    For the temporary relief of:

    • minor aches and pains including those affecting the back, legs, joints and related discomforts due to muscle strain, spasms or overexertion
    • pressure-caused discomforts due to periodic excess water retention
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  • Warnings

    Liver Warning: This product contains acetaminophen.  Severe liver damage may occur If you take

    • more than 8 pills In 24 hours, which is the maximum dally amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product.
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  • DO NOT USE

    Do not use 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 you have liver disease.

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

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  • Stop use and ask a doctor if

    • pain gets worse or lasts more than ten days
    • fever gets worse or lasts more than three days
    • redness or swelling is present
    • any new symptoms occur.
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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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.

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  • Directions

    • Read all package directions and warnings before use and use only as directed.
    • Adults: Two (2) pills with a full glass of water every 6 hours while symptoms persist, not to exceed 4 doses (8 pills) in 24 hours, or as directed by a doctor.
    • Do not exceed recommended dosage.
    • 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

    • Magnesium content: 5 mg/pill
    • **CONTENTS--SEALED: Each BACKAID MAX golden­-colored, oval shaped pill bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing. Do not use if 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 Calcium sulfate, croscarmellose sodium, D&C Yellow #10 Lake, FD&C yellow #6 Lake, hypromellose, magnesium oxide, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, potassium gluconate, sodium lauryl sulfate, sodium starch glycolate, sorbitol, starch, stearic acid, titanium dioxide.

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  • QUESTIONS

    Questions?  1-800-792-2582.

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  • Package insert

    Aspirin Free

    Backache Relief

    BACKAID Max

    1000 mg Strong per Dose

    Dual Relief Formula:

    • Maximum Strength Pain Relief
    • Relief From Fluid Build-up Discomforts

    Active ingredients: Each pill contains: acetaminophen 500 mg (analgesic/pain reliever) and pamabrom 25 mg (diuretic).

    Uses: For the temporary relief of minor aches and pains including those affecting the back, legs, joints and related discomforts due to muscle strain, spasms or overexertion, as well as to help reduce periodic excess water retention for relief of pressure-caused discomforts.

    Warnings

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur If you take • more than 8 pills In 24 hours, which is the maximum dally amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.

    Do not use 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 a doctor before use if you have liver disease.

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    Stop use and ask a doctor if
    • pain gets worse or lasts more than ten days
    • fever gets worse or lasts more than three days
    • redness or swelling is present
    • any new symptoms occur.

    If pregnant or breast feeding, ask a health professional before use.

    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.

    Directions:

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

    Other information:

    Magnesium content: 5 mg/pill

    **CONTENTS SEALED: Each BACKAID MAX golden-­colored, oval shaped pill bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing. Do not use if 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.

    Inactive ingredients Calcium sulfate, croscarmellose sodium, D&C yellow #10 Lake, FD&C yellow #6 Lake, hypromellose, magnesium oxide, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, potassium gluconate, sodium lauryl sulfate, sodium starch glycolate, sorbitol, starch, stearic acid, titanium dioxide.

    Questions?  1-800-792-2582

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  • INGREDIENTS AND APPEARANCE
    BACKAID  MAX
    acetaminophen, pamabrom tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52389-153
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 500 mg
    Pamabrom (Pamabrom) Pamabrom 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    Calcium sulfate dihydrate  
    Starch, corn  
    Croscarmellose sodium  
    D&C Yellow No. 10  
    FD&C Yellow No. 6  
    Hypromellose  
    Magnesium oxide  
    Magnesium silicate  
    Magnesium stearate  
    Cellulose, microcrystalline  
    Mineral oil  
    Polyethylene glycol 600  
    Potassium gluconate  
    Sodium lauryl sulfate  
    Sodium starch glycolate type a potato  
    Sorbitol  
    Stearic acid  
    Titanium dioxide  
    Povidone  
    Product Characteristics
    Color orange (Goldenrod) Score no score
    Shape OVAL Size 15mm
    Flavor Imprint Code ALVA
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-153-28 2 in 1 CARTON
    1 NDC:52389-153-01 14 in 1 BLISTER PACK
    2 NDC:52389-153-08 1 in 1 CARTON
    2 NDC:52389-153-02 28 in 1 BOTTLE, PLASTIC
    3 NDC:52389-153-38 1 in 1 CARTON
    3 NDC:52389-153-03 38 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 02/01/1992
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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