Label: PAIN RELIEVER PLUS- acetaminophen, aspirin and caffeine tablet, film coated
- NDC Code(s): 0904-5135-59
- Packager: Major Pharmaceuticals
- 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.
Updated February 14, 2020
If you are a consumer or patient please visit this version.
- Active ingredients (in each tablet)
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:
- facial swelling
- asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
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 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 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.
If pregnant or breast-feeding,
ask a health 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.
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Compare to the active
ingredients in Excedrin®
Pain Reliever Plus
Acetaminophen, Aspirin (NSAID) and Caffeine
250 mg/250 mg/65 mg
Pain Reliever / Pain Reliever Aid
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 USA
M-17 Rev. 02/20
Re-order No. 252831
INGREDIENTS AND APPEARANCE
PAIN RELIEVER PLUS
acetaminophen, aspirin and caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) 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: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (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) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;159 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5135-59 1 in 1 CARTON 11/17/1992 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 11/17/1992 Labeler - Major Pharmaceuticals (191427277) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0904-5135) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(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. 868734088 PACK(0904-5135)