BACKACHE RELIEF EXTRA STRENGTH- magnesium salicylate tetrahydrate tablet, film coated
L.N.K. International, Inc.

Disclaimer: 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.

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Quality Plus 44-338 Delisted

Active ingredient (in each caplet)

Magnesium salicylate tetrahydrate 580 mg (NSAID)*
(equivalent to 467.2 mg of anhydrous magnesium salicylate)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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 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 other drugs containing prescription or nonprescription NSAIDs [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 any other pain reliever/fever reducer

Ask a doctor before use if

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 have asthma
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

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
new symptoms occur
ringing in the ears or loss of hearing occurs
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 breast-feeding,

ask a health professional before use. It is especially important not to use magnesium salicylate 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

drink a full glass of water with each dose
adults: 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 50 mg
store at controlled room temperature 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

QUALITY
PLUS

NDC 50844-338-22

†Compare to the active ingredient in Extra Strength Doan's®

EXTRA STRENGTH
Backache
Relief
Magnesium Salicylate Tetrahydrate 580 mg (NSAID)

Pain Reliever
Relieves Backache Pain

48 Caplets

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Doan's®.
50844 REV0810B33822

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788

Quality Plus 44-338

BACKACHE RELIEF EXTRA STRENGTH
magnesium salicylate tetrahydrate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-338
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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	OVAL	Size	17mm
Flavor		Imprint Code	44;338
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50844-338-22	6 in 1 CARTON	11/07/1998	10/12/2021
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/07/1998	10/12/2021

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(50844-338)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(50844-338)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(50844-338)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(50844-338)

Revised: 10/2021

Document Id: ea043d07-f8e2-4032-b8f2-222f41dbb826

Set id: 2d177902-73c7-4d91-bb86-c2010376113b

Version: 10

Effective Time: 20211012

L.N.K. International, Inc.