Label: EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, caffeine tablet
- NDC Code(s): 79481-0062-1, 79481-0062-2, 79481-0062-3, 79481-0062-5
- Packager: Meijer, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 18, 2024
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- Drug Facts
- Drug Facts
- Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug
- Purposes Pain reliever Pain reliever Pain reliever aid
- Uses temporarily relieves minor aches and pains due to: ■ headache ■ a cold ■ arthritis ■ muscular aches ■ toothache ■ premenstrual & menstrual cramps
- 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 way. Allergy alert:Aspirin 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 a nonsteroidal anti-inflammatory drug (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 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 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 asthma
- Ask 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 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 ■ 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 appear These could be signs of a serious condition
- If pregnant or breast-feedingask 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 In case of overdose, get medical help or contact a Poison Control Center right away 1(800)222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions ■ do not use more than directed ■ drink a full glass of water with each dose ■ adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours ■ children under 12 years: ask a doctor
- Other information ■ store between 20º - 25º C (68º - 77º F)
- Inactive ingredients colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc
- Questions or comments? 1-888-333-9792
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH HEADACHE RELIEF
acetaminophen, aspirin, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0062 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white 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:79481-0062-5 1 in 1 CARTON 06/18/2024 1 50 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:79481-0062-1 1 in 1 CARTON 06/18/2024 2 100 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:79481-0062-3 2 in 1 CARTON 06/18/2024 3 NDC:79481-0062-2 100 in 1 BOTTLE; 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 06/18/2024 Labeler - Meijer, Inc. (006959555)
