Extra Strength Aspirin

Extra Strength Aspirin is an FDA-registered drug product whose active ingredient is ASPIRIN. It is labelled by HHH Pharmaceuticals taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 83586-115, application M013, label effective 20260506. It is one of 106 FDA drug label records sharing the active ingredient ASPIRIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ASPIRIN are most often described in connection with: temporary relieves, minor aches, pains due, headache muscular, pain arthritis, common cold, toothache premenstrual, menstrual cramps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporary relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps

Directions drink a full glass of water with each dose adults and children 12 years and over: • take 1 to 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours children under 12 years: ask a doctor

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 shock facial swelling asthma (wheezing) 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 time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if you have asthma 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 Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis under a doctor's care for any serious condition taking any other drug Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better an allergic reaction occurs. Seek medical help right away. ringing in the ears or a loss of hearing occurs pain gets worse or lasts for more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 106 drug label records with ASPIRIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Extra Strength Aspirin used for?
Uses temporary relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps

Who makes Extra Strength Aspirin?
HHH Pharmaceuticals is the labeler of record for Extra Strength Aspirin. 106 FDA label records share the active ingredient ASPIRIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Extra Strength Aspirin come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Extra Strength Aspirin prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ASPIRIN?
Yes. 106 FDA drug label records list ASPIRIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Extra Strength Aspirin been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.