Label: PAIN TERMINATOR EXTRA STRENGTH PAIN RELIEF- caffeine, acetaminophen, aspirin capsule
- NDC Code(s): 84269-2533-1, 84269-2533-2
- Packager: Wildman Business Group
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 1, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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: 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.
Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 caplets in 24 hours, which is the maximum daily amount
- 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)
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
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
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.
- if you ever have had an allergic reaction to acetaminophen, aspirin or any other pain relievers/ fever reducers
ASK DOCTOR
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
- you have asthma
- you have liver disease
ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for gout, diabetes, or arthritis
- taking any other drug, or under a doctor's care for any serious condition
STOP USE
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
- 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
- painful area is red or swollen
- any new symptoms appear
These could be signs of a serious condition.
PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Principal Display Panel – 100 Caplet Box Label
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INGREDIENTS AND APPEARANCE
PAIN TERMINATOR EXTRA STRENGTH PAIN RELIEF
caffeine, acetaminophen, aspirin capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84269-2533 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color white (white to off white with specks) Score no score Shape CAPSULE (capsule shaped, biconvex) Size 18mm Flavor Imprint Code S53 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84269-2533-2 100 in 1 BOX 07/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:84269-2533-1 50 in 1 BOX 07/01/2024 2 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/01/2024 Labeler - Wildman Business Group (016677338) Establishment Name Address ID/FEI Business Operations Elysium Pharmaceuticals LTD. 863182240 MANUFACTURE(84269-2533) Establishment Name Address ID/FEI Business Operations Medique Products 086911794 PACK(84269-2533) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 PACK(84269-2533)