Extra Strength Pain Reliever mini softgels

Extra Strength Pain Reliever mini softgels is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN 500 MG. It is labelled by Shield Pharmaceuticals Corp taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 83059-0168, application M013, label effective 20260804. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN 500 MG. 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 ACETAMINOPHEN 500 MG are most often described in connection with: temporarily relieves, minor aches, pains due, common cold, headache backache, pain arthritis, toothache muscular, menstrual cramps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions do not use more than directed (see overdose warning ) adults and children 12 years and over: take 2 softgels every 6 hours while symptoms last do not take more than 6 softgels in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years: ask a doctor

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning 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.

FDA lists 3 drug label records with ACETAMINOPHEN 500 MG 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 Pain Reliever mini softgels used for?
Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Who makes Extra Strength Pain Reliever mini softgels?
Shield Pharmaceuticals Corp is the labeler of record for Extra Strength Pain Reliever mini softgels. 3 FDA label records share the active ingredient ACETAMINOPHEN 500 MG, 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 Pain Reliever mini softgels 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 Pain Reliever mini softgels 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 ACETAMINOPHEN 500 MG?
Yes. 3 FDA drug label records list ACETAMINOPHEN 500 MG 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 Pain Reliever mini softgels 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.