PAIN RELIEVER PLUS- acetaminophen, aspirin and caffeine tablet, film coated
Major Pharmaceuticals
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Major 44-159B Delisted
Active ingredients (in each tablet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- headache
- a cold
- arthritis
- muscular aches
- toothache
- premenstrual and menstrual cramps
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 may cause a severe allergic reaction, which may include:
- shock
- facial swelling
- hives
- asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin 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
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
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
- 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
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- 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 have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- you have liver disease
- 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 have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug or are under a doctor's care for any serious condition
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 a loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
Directions
- do not take more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours
- children under 12 years: ask a doctor
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Principal Display Panel
MAJOR®
NDC 0904-5135-59
Compare to the
active ingredients in
Excedrin® Extra Strength†
Pain Reliever Plus
Acetaminophen, Aspirin (NSAID), and Caffeine
250 mg/250 mg/65 mg
Pain Reliever / Pain Reliever Aid
Actual Size
100 Coated Tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by GSK Consumer
Healthcare S.A., owner of the registered trademark Excedrin® Extra
Strength. 50844 REV1119G15912
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
44-159B
| PAIN RELIEVER PLUS
acetaminophen, aspirin and caffeine tablet, film coated |
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| Labeler - Major Pharmaceuticals (191427277) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | pack(0904-5135) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | manufacture(0904-5135) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | manufacture(0904-5135) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | pack(0904-5135) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 117025878 | manufacture(0904-5135) | |