Your browser does not support JavaScript! BACKAID MAX (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [ALVA-AMCO PHARMACAL COMPANIES, INC.]
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BACKAID MAX (acetaminophen, pamabrom) tablet, film coated
[Alva-Amco Pharmacal Companies, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Active ingredients (in each pill)

Acetaminophen, 500 mg

Pamabrom, 25 mg

Purpose

Analgesic (pain reliever)

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
  • 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 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.

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

Back Aid Max PDP

BACKAID  MAX
acetaminophen, pamabrom tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52389-153
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg
Pamabrom (Pamabrom) Pamabrom25 mg
Inactive Ingredients
Ingredient NameStrength
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
Colororange (Goldenrod) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-153-282 in 1 CARTON
1NDC:52389-153-0114 in 1 BLISTER PACK
2NDC:52389-153-081 in 1 CARTON
2NDC:52389-153-0228 in 1 BOTTLE, PLASTIC
3NDC:52389-153-381 in 1 CARTON
3NDC:52389-153-0338 in 1 BOTTLE, PLASTIC
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)

Revised: 9/2010
 
Alva-Amco Pharmacal Companies, Inc.

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