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BACK RELIEF

North Safety Products LLC

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 200 mg

Magnesium salicylate 200 mg (NSAID)

Purpose

Pain reliever, Fever Reducer

Uses

temporary relieves minor aches and pains associated with:

backache headache colds toothache minor arthritis pain muscular aches menstrual cramps and to reduce fever


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

Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take: ore than 12 tablets in 24 hours, which is the maximum daily amount, with any other drug containing acetaminophen (prescription or nonprescription)3 or more alcoholic drinks every day while taking this product

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 any other drugs containing precription or nonprescription NSAIDs (aspirin,ibuprofen,naproxen or others) take more or for longer time than directed

Do not use: if you ever had an allergic reaction to any other pain reliever/fever reducer do not take this product if you are allergic to salicylates (including aspirin) unless directed by a doctor

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

with any other drug containing an NSAID (prescription or nonprescription)

Ask a doctor before using if you are not sure

Ask a doctor or pharmacist before use if you have liver disease

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 are taking a diuretic

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

ringing in the ears or loss of hearing occurs

pain lasts for more than 5 days or fever gets worse or lasts more than 3 days

redness or swelling is present in the painful area

new symptoms appear

Directions do not take more than directed the smallest effective dose should be used

adults and children 12 years of age and over:drink a full glass of water with each dose

take 2 tablets every 4 hours do not take more than 12 tablets in 24 hours

do not take longer than 10 days,unless directed by a doctor

children under 12 years:ask a doctor


Inactive ingredients DC red 28, microcrystalline cellulose, povidone, starch, stearic acid

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 specifically directed to do so by a doctor

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

Keep out of the reach of children: In case of overdose get medical help or contact a Poison Control

center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms

MM1BACK RELIEF

BACK RELIEF

ACETAMINOPHEN, MAGNESIUM SALICYLATE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0498-2101
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 200 mg
Magnesium Salicylate SALICYLIC ACID 200 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
STARCH, CORN
STEARIC ACID
D&C RED NO. 28

Product Characteristics

Color Size Imprint Code Shape
pink (Pink) 12 mm FR1 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0498-2101-01 2 in 1 PACKET
2 NDC:0498-2101-10 50 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-05-14


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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