BACK RELIEF- acetaminophen, magnesium salicylate tablet 
Honeywell Safety Products USA, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0498-2102: Back Relief

Active Ingredients (in each tablet)

Acetaminophen 200 mg

Magnesium salicylate 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever, fever reducer

Pain reliever, fever reducer

Uses

temporary reduces fever and relieves minor aches and pains due to

a cold, headache, toothache, muscular aches, arthritis, premenstrual and menstrualcramps,

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: magnesium salicylate may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma(wheezing)
  • shock

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.

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

  • more than 4,00 mg in 24 hours, which is the maximum daily amount,
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while taking this product

Stomach bleeding warning: This product contains an 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 (anticoagulant) or steroid drug
  • take any other drugs containing precription or nonprescription NSAIDs (aspirin,ibuprofen,naproxen or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for longer time than directed

Do not use

  • if you ever had an allergic reaction to acetaminophen, magnesium salicylate or any other pain reliever/ fever reducer
  • with any other drugs containing acetaminophen (prescription or nonprescription). 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
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

Stop using and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days'
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present in painful area
  • ringing in the ears or a loss of hearing occurs
  • any new symptoms appear.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to

use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor

because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

Overdose warning:In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years of age and over:
  • take 2 tablets every 6 hours do not take more than 8 tablets in 24 hours
  • children under 12 years:ask a doctor

Other Information

  • each tablet contains 19mg of magnesium
  • store at room temperature 15 o-30 oC (59 o-86 oF)
  • avoid excessive heat and humidity
  • TAMPER EVIDENT- DO NOT USE IF OPEN OR TORN

Inactive Ingredients

D&C red #28, microcrystalline cellulose, povidone, starch, stearic acid

Questions or comments

1-800-430-5490

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Back Relief label

Honeywell Back Relief

BACK RELIEF 
acetaminophen, magnesium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN200 mg
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
Product Characteristics
Colorpink (Pink) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2101-1050 in 1 CARTON05/14/201312/20/2017
1NDC:0498-2101-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/14/201312/20/2017
BACK RELIEF 
acetaminophen, magnesium salicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN200 mg
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
Product Characteristics
Colorpink (Pink) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2102-10100 in 1 CARTON12/20/2017
1NDC:0498-2102-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/201712/29/2022
Labeler - Honeywell Safety Products USA, Inc (118768815)

Revised: 1/2024
 
Honeywell Safety Products USA, Inc