MAXIMUM STRENGTH BACKACHE RELIEF- magnesium salicylate capsule, coated

Maximum Strength Backache Relief by

Drug Labeling and Warnings

Maximum Strength Backache Relief by is a Otc medication manufactured, distributed, or labeled by JHK DBA American Safety & First Aid, LNK International, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (In Each Caplet)

Magnesium salicylate tetrahydrate 580 mg (NSAID)1 (equivalent to 467.2 mg of anhydrous magnesium salicylate)

1 Nonsteroidal Anti-Inflammatory Drug

Purpose

pain reliever/fever reducer

Use

for the temporary relief of minor backache pain

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

Stomach bleeding warning

This product contains a nonsteroidal anti-inflammatory drug (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 other drugs containing a prescription or nonprescription NSAID (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do not use

• if you are allergic to salicylates (including aspirin) or to any other pain reliever/fever reducer
• for more than 10 days for pain unless directed by a doctor

Ask doctor before use if:

• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

taking a prescription drug for

• gout
• diabetes
• arthritis

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right away.
• 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
  • if ringing in the ears or loss of hearing occurs new symptoms occur
  • new symptoms occur
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use magnesium salicylate at 20 weeks or later in 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• drink a full glass of water with each dose
• adults and children 12 years and over: take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours
• children under 12 years: do not use unless directed by a doctor.

Other Information

• Each caplet contains: magnesium 40mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• tamper evident sealed packets
• do not use if packet is opened or torn

Inactive ingredient

hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin

Questions?

1-866-651-3660 Monday-Friday 8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 580 mg Caplet Packet Carton

This product is not manufactured or distributed by
Dr Reddy's Laboratories, Inc
Owner of the registered trademark Doan's®.

Maximum Strength
Backache Relief

Product #1272

Pain Reliever/Fever Reducer

Active ingredient:
Magnesium Salicylate

• Temporary relief from pain, fever, and inflammation
• Soothes muscle aches and minor arthritis pain

These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2021 standards. They are sealed in
tamper-evident packets for safety and convenience.

80 Caplets 2 Caplets Per Packet

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH BACKACHE RELIEF 
magnesium salicylate capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-1272
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MAGNESIUM SALICYLATE	580 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	44;338
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73598-1272-1	40 in 1 CARTON	06/26/2024
1		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 Drug	M013	06/26/2024

Labeler - JHK DBA American Safety & First Aid (867236309)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, INC		832867837	MANUFACTURE(73598-1272)