MEDIQUE BACK PAIN OFF- magnesium salicylate/acetaminophen/caffeine tablet, film coated

MEDIQUE Back Pain Off by

Drug Labeling and Warnings

MEDIQUE Back Pain Off by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation, Prestige Packaging, Medique Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 250 mg

Caffeine 50 mg

Magnesium Salicylate (NSAID*) 290 mg

magnesium (total) 19 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Pain reliever aid

Analgesic

Uses

For the temporary relief of minor aches and pains associated with

• back pain
• muscular aches

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:

Salicylates (NSAIDs) 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 or allergic 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 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using 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 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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for pain for more than 10 days unless directed by a doctor
• for fever for more than 3 days unless directed by a doctor
• if you ever have had an allergic reaction to any other pain relievers/ fever reducers
• right before or after heart surgery
• if you are taking prescription drugs for gout, diabetes, or arthritis

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• under a doctor's care for any serious condition
• taking any other drug

When using this product

• take with food or milk if stomach upset occurs

Stop use 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
• symptoms do not improve
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• ringing in the ears or loss of hearing occurs
• redness or swelling is present in the painful area
• any new symptoms appears

If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use salicylates (NSAIDs) 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed

Adults and children (12 years and older): Take 2 tablets with water every 6 hours while symptoms persist. Do not exceed 8 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Other information

• each dose contains 38mg of magnesium
• read all product information before using
• store at room temperature 59º-86ºF (15º-30ºC)
• avoid excessive heat and humidity
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide

Questions or comments?

1-800-634-7680

Medique Back Pain-Off Label

Medique®

Back Pain-Off

Back Pain Relief

This Package is for Households without Young Children.

Pull to Open

Aches, Fevers Acetaminophen 250 mg

Pain Reliever Aid Caffeine50 mg

Pain Relief Magnesium Salicylate (NSAID) 290 mg,

200 Tablets

(100 x 2)

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

MEDIQUE BACK PAIN OFF 
magnesium salicylate/acetaminophen/caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-073
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MAGNESIUM SALICYLATE	290 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	50 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	FR;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-073-33	50 in 1 BOX	12/30/2008
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-073-47	100 in 1 BOX	12/30/2008
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-073-13	250 in 1 BOX	12/30/2008
3	NDC: 47682-073-99	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	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	repack(47682-073) , relabel(47682-073)