MEDIQUE PAIN OFF
-
acetaminophen,
aspirin and
caffeine tablet, film coated
Unifirst First Aid Corporation
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Medique Pain OffDrug Facts
Active ingredients (in each tablet)
Acetaminophen 250 mg
Aspirin (NSAID*) 250 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Pain reliever/fever reducer
Stimulant
Uses:
- headache
- muscular aches
- minor arthritis pain
- back pain
- common cold
- toothache
- menstrual cramps
Temporarily reduces 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: Aspirin (NSAID) 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 appear
If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin 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 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 as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 years:
Do not give to children under 12 years of age.
Other information
- read all product information before using
- store at room temperature 59°-86°F (15°-30°C)
- 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
Principal Display Panel
Principal Display Panel - 228R Medique Pain-Off Label
Medique®
Pain-Off
Aspirin (NSAID), Acetaminophen
& Caffeine Formula
Pull to Open
Easy to Swallow
Film Coated Tablets
See new warnings information
100 Tablets
(50 x 2)
Tamper Evident Unit Dose Packets
| MEDIQUE PAIN OFF
acetaminophen, aspirin, caffeine tablet, film coated |
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| 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) |