Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN, ASPIRIN, CAFFEINE
Labeler / manufacturerHyVee Inc
RouteORAL
Drug classNonsteroidal Anti-inflammatory Drug / Platelet Aggregation Inhibitor / Central Nervous System Stimulant / Methylxanthine
Product NDC42507-142
Label effective date2026-08-24
Official product label reference
HyVee Extra Strength Headache Relief CAPLET — HyVee Inc
This page contains 10 source sections for ACETAMINOPHEN, ASPIRIN, CAFFEINE, oral route. Label set 495c75bf-c09a-accd-e063-6294a90a75ec, version 2.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps
Purpose
Purposes Pain reliever Pain reliever Pain reliever aid
Dosage and administration — label text
Directions • do not use more than directed • drink a full glass of water with each dose • adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours • children under 12 years of age: ask a doctor
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 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) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer lime 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 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 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. Keep out of reach of children. Overdose warning, In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Unclassified section
Drug Facts
* Compare to the Active Ingredients of Excedrin ® Extra Strength READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION DISTRIBUTED BY HY-VEE, INC. WEST DES MOINES, IA 50266 PRODUCT OF INDIA SATISFACTION GUARANTEED CALL 1-800-289-8343 www.hy-vee.com *This product is not manufactured or distributed by Haleon US Holdings LLC., distributor of Excedrin ® Extra Strength. TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Active ingredient
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID**) Caffeine 65 mg **nonsteroidal anti-inflammatory drug
Child safety
Keep out of reach of children. Overdose warning, In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Storage and handling
Other information • store at 20-25°C (68-77°F) • keep bottle tightly closed • protect from light, heat and moisture
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.