Label: KROGER EXTRA STRENGTH HEADACHE RELIEF GELTAB- acetaminophen, aspirin, caffeine tablet, film coated
- NDC Code(s): 59450-600-80
- Packager: The Kroger Co.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 29, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each geltab)
- 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: 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 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 geltabs 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 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 are taking a diuretic
• you have asthmaAsk a doctor or pharmacist before use if you are taking
• a prescription drug for diabetes, gout, or arthritis
• any other drug, or are under a doctor’s care for any serious conditionStop 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
• painful area is red or swollen
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• any 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.
- Directions
- Other information
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Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, edible black ink, ethyl cellulose, FD&C blue#1, FD&C blue#1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, isopropyl alcohol, lactose monohydrate, light mineral oil, microcrystalline cellulose, povidone, pregelatinized potato starch, purified water, sorbitol sorbitan solution, stearic acid, talc, titanium dioxide, triacetin
- Questions or comments?
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SPL UNCLASSIFIED SECTION
COMPARE TO THE ACTIVE INGREDIENTS IN EXCEDRIN® EXTRA STRENGTH *See bottom panel
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, distributor of Excedrin® Extra Strength
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
Product of United Arab EmiratesREAD AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
- Packaging
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INGREDIENTS AND APPEARANCE
KROGER EXTRA STRENGTH HEADACHE RELIEF GELTAB
acetaminophen, aspirin, caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59450-600 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 STARCH, CORN (UNII: O8232NY3SJ) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) LIGHT MINERAL OIL (UNII: N6K5787QVP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, POTATO (UNII: 8I089SAH3T) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color green, white Score no score Shape ROUND Size 13mm Flavor Imprint Code S77 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59450-600-80 1 in 1 CARTON 02/01/2024 1 80 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 Drug M013 02/01/2024 Labeler - The Kroger Co. (006999528)