Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 73598-1372 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Extra strength pain reliever |
||||||
| Type | Brand | ||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS] |
||||||
| Active Ingredients |
|
||||||
| Route | ORAL | ||||||
| Dosage Form | CAPSULE, COATED | ||||||
| Application Number | M013 | ||||||
| Labeler Name | JHK Inc dba American Safety & First Aid | ||||||
| Packages |
|
||||||
| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (In Each Caplets) Purpose Acetaminophen 250 mg pain reliever/fever reducer Aspirin 250 mg (NSAID) Nonsteroidal Anti-Inflammatory Drug pain reliever/fever reducer Caffeine 65 mg pain reliever aid
| Acetaminophen 250 mg | pain reliever/fever reducer |
| Aspirin 250 mg (NSAID) | pain reliever/fever reducer |
| Caffeine 65 mg | pain reliever aid |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults 2 tablets, with water every 6 hours while symptoms persist; not to exceed 8 tablets in 24 hours or as directed by a doctor. Children under 12 years: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Polyethylene Glycol, Pregelatinized Starch, Starch 1500, Stearic Acid, Talc
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use temporarily relieves fever and minor aches and pains associated with: headache colds muscular aches menstrual discomfort toothaches minor arthritis pain
Purpose
Information about the drug product’s indications for use.Active ingredient (In Each Caplets) Purpose Acetaminophen 250 mg pain reliever/fever reducer Aspirin 250 mg (NSAID) Nonsteroidal Anti-Inflammatory Drug pain reliever/fever reducer Caffeine 65 mg pain reliever aid
| Acetaminophen 250 mg | pain reliever/fever reducer |
| Aspirin 250 mg (NSAID) | pain reliever/fever reducer |
| Caffeine 65 mg | pain reliever aid |
Spl product data elements
Usually a list of ingredients in a drug product.Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN, and CAFFEINE ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN STEARIC ACID TALC S53
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box This product is not manufactured or distributed by Novartis Owner of the registered trademark Excedrin ® . Product #1372 Extra Strength Pain Reliever Pain Reliever/Fever Reducer Active ingredient: Acetaminophen, Aspirin Caffeine Temporary relief from pain, fever, and inflammation Soothes muscle aches and minor arthritis pain These quality comfort caplets are formulated and packaged for use in the workplace and meet ANSI Z308. 1-2021 standards. They are sealed in tamper-evident packets for safety and convenience. 50 Caplets • 2 Caplets Per Packet PRINCIPAL DISPLAY PANEL - 50 Caplet Packet Box
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask doctor before use if stomach bleeding warning applies to you you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease you are taking diuretic you have a history of stomach problems, such as heartburn
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of blood) diabetes gout arthritis
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you are allergic to aspirin with any other pain reliever/fever reducer if you have ever had an allergic reaction to any other pain reliever/fever reducer for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST Manufactured for American Safety & First Aid Osceola, IN 46561
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask doctor if 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 pain or fever persists or gets worse New symptoms occur Redness or swelling is present
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not exceed recommended dose.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding , ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.
Storage and handling
Information about safe storage and handling of the drug product.Other Information do not use if packet is opened or torn store at room temperature 68º-77ºF (20º-25ºC) avoid excessive heat and humidity each caplet contains: Magnesium 0.58 mg
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 Liver Warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets 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 a prescription or nonprescription NSAID (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 dosage 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 if you are allergic to aspirin with any other pain reliever/fever reducer if you have ever had an allergic reaction to any other pain reliever/fever reducer for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask doctor before use if stomach bleeding warning applies to you you have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma or kidney disease you are taking diuretic you have a history of stomach problems, such as heartburn Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of blood) diabetes gout arthritis When using this product do not exceed recommended dose. Stop use and ask doctor if 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 pain or fever persists or gets worse New symptoms occur Redness or swelling is present If pregnant or breastfeeding , ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API