![PAIN RELIEVER PLUS (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]](https://medic.hrt.org//dailymed/images/17079b90-ccb2-4f35-8641-fdf3613d834f/17079b90-ccb2-4f35-8641-fdf3613d834f-01.jpg)
| NDC | 58118-5135-0, 58118-5135-3, 58118-5135-6, 58118-5135-8, 58118-5135-9 |
| Set ID | 17079b90-ccb2-4f35-8641-fdf3613d834f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Clinical Solutions Wholesale |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredients (in each tablets)
- Purpose
- Uses
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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 naussea 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:
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- hives
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- facial swelling
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- shock
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- asthma (wheezing)
Liver warning: This product contains acetaminophen. Severe lliver damage may occur if you take:
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- more than 8 tablets in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 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:
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- are age 60 or older
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- hae had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs [aspiring, ibuprofen, naproxen or others]
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- have 3 or more alcoholic drinks every day while using this product
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- 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, occasionaly, rapid heartbeat.
Do not use
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- if you ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
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- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
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- you have liver disease
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- stomach bleeding warning appies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
Ask a doctor or pharmacist before use if you are
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- taking a prescription drug for diabetes, gout, or arthritis
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- taking any other drug or are under a doctor's care for any serious condition
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- have bloody or black stools
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- vomit blood
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- have stomach pain that does not get better
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- an allergic reaction occurs. Seek medical help right away.
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- any new symptoms appear
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- ringing in the ears or loss of hearing occurs
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- pain gets worse or lasts for more than 10 days
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- fever gets worse or lasts for more than 3 days
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- painful area is red or swollen
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
MAJOR®
COMPARE TO the active ingredients in EXCEDRIN® Extra Strength†
PAIN RELIEVER
PLUS
Acetaminophen, Aspirin (NSAID) and caffeine
Pain Reliever / Pain Reliever AidTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excederin® Extra Strength.
50844 REV0713C15912Distributed by MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA M-17 Rev. 08/13
Re-order No. 252831 -
INGREDIENTS AND APPEARANCE
PAIN RELIEVER PLUS
acetaminophen, aspirin and caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58118-5135(NDC:0904-5135) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 68401960MK) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 13mm Flavor Imprint Code 44;159 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58118-5135-3 30 in 1 BOTTLE, PLASTIC 2 NDC:58118-5135-6 60 in 1 BOTTLE, PLASTIC 3 NDC:58118-5135-9 90 in 1 BOTTLE, PLASTIC 4 NDC:58118-5135-8 30 in 1 BLISTER PACK 5 NDC:58118-5135-0 1 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/17/1992 Labeler - Clinical Solutions Wholesale (078710347) Registrant - Clinical Solutions Wholesale (078710347) Establishment Name Address ID/FEI Business Operations Clinical Solutions Wholesale 078710347 REPACK(58118-5135) , RELABEL(58118-5135)
