FDA Label for Backaid Max

View Indications, Usage & Precautions

Backaid Max Product Label

The following document was submitted to the FDA by the labeler of this product Kobayashi Healthcare International, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Otc - 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

Otc - Ask Doctor



Ask a doctor before use if you have liver disease.


Otc - 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

Otc - Pregnancy Or Breast Feeding



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


Otc - 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 silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, potassium gluconate, sodium lauryl sulfate, sodium starch glycolate, sorbitol, starch, stearic acid, titanium dioxide.


Otc - 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 silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, polyvinylpyrrolidone, potassium gluconate, sodium lauryl sulfate, sodium starch glycolate, sorbitol, starch, stearic acid and titanium dioxide.

      Questions?  1-800-792-2582


* Please review the disclaimer below.