Label: PAIN RELIEVER PLUS- acetaminophen, aspirin and caffeine tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 58118-5135-0, 58118-5135-3, 58118-5135-6, 58118-5135-8, view more58118-5135-9 - Packager: Clinical Solutions Wholesale
- This is a repackaged label.
- Source NDC Code(s): 0904-5135
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 1, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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)
