BACK RELIEF- acetaminophen, magnesium salicylate tablet

BACK RELIEF by

Drug Labeling and Warnings

BACK RELIEF by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

Back Relief label

INGREDIENTS AND APPEARANCE

BACK RELIEF 
acetaminophen, magnesium salicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-2101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	200 mg
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MAGNESIUM SALICYLATE	200 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
D&C RED NO. 28 (UNII: 767IP0Y5NH)

Product Characteristics
Color	pink (Pink)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-2101-10	50 in 1 CARTON	05/14/2013	12/20/2017
1	NDC: 0498-2101-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/14/2013	12/20/2017

BACK RELIEF 
acetaminophen, magnesium salicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-2102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	200 mg
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MAGNESIUM SALICYLATE	200 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
D&C RED NO. 28 (UNII: 767IP0Y5NH)

Product Characteristics
Color	pink (Pink)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0498-2102-10	100 in 1 CARTON	12/20/2017
1	NDC: 0498-2102-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/20/2017

Labeler - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	manufacture(0498-2101) , repack(0498-2102)