BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]

BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]
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NDC 52389-153-01, 52389-153-03, 52389-153-14, 52389-153-28, 52389-153-35, 52389-153-38, 52389-153-46
Set ID fb9a5647-b7c9-4820-b148-91060e34cb83
Category HUMAN OTC DRUG LABEL
Packager Alva-Amco Pharmacal Companies, Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredients (in each caplet)

    Acetaminophen, 500 mg

    Pamabrom, 25 mg

  • Purpose

    Analgesic (pain reliever)

    Diuretic

  • Uses

    For the temporary relief of:

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

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

    • more than 6 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.

    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.

  • 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.
    • 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 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 and ask a doctor if

    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse
  • 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. 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. Use only as directed.
    • Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) 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/caplet
    • **CONTENTS SEALED: Each BACKAID MAX golden­-colored, oval shaped caplet 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 INGREDIENT

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

  • QUESTIONS

    Questions?  1-800-792-2582.

  • Package insert

    Aspirin Free

    Backache Relief

    BACKAID Max

    1000 mg Strong per 2 Caplet Dose

    Maximum Strength 6 Hour Formula

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

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

    Warnings

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 caplets 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.

    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.

    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. • 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 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

    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse

    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. Use only as directed.
    • Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) 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/caplet

    **CONTENTS SEALED: Each BACKAID MAX golden-­colored, oval shaped caplet 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 stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, potassium gluconate, sodium lauryl sulfate, sodium starch glycolate, sorbitol, starch, stearic acid, talc and titanium dioxide.

    Questions? 1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    BackAidMaxPDP

  • INGREDIENTS AND APPEARANCE
    BACKAID  MAX
    acetaminophen, pamabrom tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-153
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POTASSIUM GLUCONATE (UNII: 12H3K5QKN9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Colororange (Goldenrod) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code ALVA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52389-153-282 in 1 CARTON03/01/2011
    1NDC:52389-153-0114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:52389-153-141 in 1 CARTON06/01/2011
    2NDC:52389-153-0114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:52389-153-381 in 1 CARTON09/01/2010
    3NDC:52389-153-0338 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:52389-153-461 in 1 CARTON04/29/2016
    446 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:52389-153-355 in 1 CARTON06/01/2011
    57 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/01/1992
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

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