Label: GENCARE HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet
- NDC Code(s): 72090-033-01
- Packager: Pioneer Life Sciences, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 17, 2024
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- Official Label (Printer Friendly)
- Active Ingredients (in each caplet)
-
Purpose
Acetaminophen 250 mg............................................................Pain reliever
Aspirin 250 mg (NSAID*)..........................................................Pain reliever
Caffeine 65 mg ..................................................................Pain reliever aid
(*nonsteroidal anti-inflammatory drug) - Uses:
-
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
•rashIf a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
•hives
•facial swelling
•asthma (wheezing)
•shockLiver 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 productStomach 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)
•have 3 or more alcoholic drinks every day while using this product
•take more or for a longer time than directedCaffeine 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 have 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. - Ask Doctor:
- ASK DOCTOR/PHARMACIST:
-
STOP USE
Stop use and ask 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■painful area is red or swollen
■pain gets worse for more than 10 days
■fever gets worse or lasts more than 3 days
■any new symptoms occur. These could be signs of a serious condition.
- PREGNANCY
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GENCARE HEADACHE RELIEF
acetaminophen, aspirin, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72090-033 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code HH6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72090-033-01 300 in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 10/18/2024 Labeler - Pioneer Life Sciences, LLC (014092742)