Label: EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin and caffeine tablet, film coated
- NDC Code(s): 82804-163-60
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 57896-216
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 1, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- 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 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:
• hives • facial swelling • asthma (wheezing) • shock
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • rash
• skin reddening • blisters 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 • 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 • 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) • are age 60 or older
• have 3 or more alcoholic drinks every day while using this product
• 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 heartbeat. -
DO NOT USE
Do not use
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- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
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- 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
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- you have liver disease
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- stomach bleeding warning applies 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
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- you are taking a diuretic
- •
- you have asthma
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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- an allergic reaction occurs. Seek medical help right away.
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- ringing in the ears or loss of hearing occurs
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- painful area is red or swollen
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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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- 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. - KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- INACTIVE INGREDIENTS
- Questions or comments?
- Package label
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEVER
acetaminophen, aspirin and caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82804-163(NDC:57896-216) 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape CAPSULE (CAPSULE SHAPED TABLET) Size 17mm Flavor Imprint Code 44;334 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82804-163-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 02/01/2020 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(82804-163) , RELABEL(82804-163)
