MEDIQUE BACK PAIN OFF- magnesium salicylate, acetaminophen and caffeine tablet, film coated 
Unifirst First Aid Corporation

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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MEDIQUE Back Pain Off

Drug Facts

Active ingredients (in each tablet)

Magnesium Salicylate (NSAID*) 290 mg

magnesium (total) 19 mg

Acetaminophen 250 mg

Caffeine 50 mg

*nonsteroidal anti-inflammatory drug

Purposes

Analgesic

Pain reliever/fever reducer

Stimulant

Uses

For the temporary relief of minor aches and pains associated with:

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
  • skin reddening
  • facial swelling
  • rash
  • asthma (wheezing)
  • shock
  • blisters

If an 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 8 tablets in 24 hours, which is the maximum daily amount for this product
  • 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 more than 3 days for fever 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

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

Inactive ingredients

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

Questions or comments? 1-800-634-7680

Principal Display Panel - 073R Medique Back Pain-Off Label

Medique®

Back Pain-Off

See new warnings information

Magnesium Salicylate (NSAID),

Acetaminophen and Caffeine Formula

Pull to Open

Easy To Swallow

Film Coated Tablets

100 Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

Principal Display Panel - 073R Medique Back Pain-Off Label
MEDIQUE BACK PAIN OFF 
magnesium salicylate/acetaminophen/caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:47682-073
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Magnesium Salicylate (SALICYLIC ACID) Magnesium Salicylate290 mg
Acetaminophen (ACETAMINOPHEN) Acetaminophen250 mg
Caffeine (CAFFEINE) Caffeine50 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
HYPROMELLOSE 
MALTODEXTRIN 
POLYETHYLENE GLYCOL 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint Code FR;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-073-3350 in 1 BOX, UNIT-DOSE
1NDC:47682-073-992 in 1 PACKET
2NDC:47682-073-47100 in 1 BOX, UNIT-DOSE
2NDC:47682-073-992 in 1 PACKET
3NDC:47682-073-13250 in 1 BOX, UNIT-DOSE
3NDC:47682-073-992 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/30/2008
Labeler - Unifirst First Aid Corporation (832947092)

Revised: 9/2010
Document Id: c53078c7-0530-4ca2-b000-2d01461b751c
Set id: 88332ea4-3322-415f-a7fd-3e51a872daf6
Version: 1
Effective Time: 20100928
 
Unifirst First Aid Corporation