Unishield Back Pain Off by Unishield / Unifirst First Aid Corporation Unishield Back Pain-Off
Unishield Back Pain Off by
Drug Labeling and Warnings
Unishield Back Pain Off by is a Otc medication manufactured, distributed, or labeled by Unishield, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
UNISHIELD BACK PAIN OFF- acetaminophen, caffeine, magnesium salicylate tablet, film coated
Unishield
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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Unishield Back Pain-Off
Active ingredients (in each tablet)
Acetaminophen 250 mg
Caffeine 50 mg
Magnesium Salicylate (NSAID*) 290 mg
magnesium (total) 20 mg
*nonsteroidal anti-inflammatory drug
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, which is the maximum daily amount
■ 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
■ if you ever have had an allergic reaction to acetaminophen, salicylates (NSAIDs) or any other pain
relievers/ fever reducers
■ 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 more than 10 days unless directed by a doctor
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 prescription drugs for gout, diabetes, or arthritis
■ taking the blood thinning drug warfarin
■ under a doctor’s care for any serious condition
■ taking any other drug
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
■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
■ drink a full glass of water with each dose
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 or as directed by a doctor.
Children under 12 years: Ask a doctor
Other information
■ each dose contains 40 mg 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, starch, stearic acid, titanium dioxide
Unishield Back Pain-Off
Unishield
Back Pain-Off
Back Pain Relief
100 Tablets/2Tablets Per Packet
Acetaminophen 250 mg
Caffeine 50 mg
Magnesium Salicylate (NSAID) 290 mg
Pull To Open
This Package is for Households Without Young Children.
Relieves backaches, muscular aches & Pains
Extra Strength Pasin Relief
Fast Acting Advanced Formula
Tamper Evident Unit Dose Packets
| UNISHIELD BACK PAIN OFF
acetaminophen, caffeine, magnesium salicylate tablet, film coated |
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| Labeler - Unishield (790677053) |
| Registrant - Unifirst First Aid Corporation (832947092) |
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