SED-MAX

SED-MAX is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG. It is labelled by Command Brands, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69197-029, application M013, label effective 20170119. 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 WITH CAFFEINE 65MG are most often described in connection with: temporary relief, minor aches, pains due, headache muscular. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporary relief of minor aches and pains due to: ■ headache ■ muscular aches

Directions ■ do not use more than directed ■ Adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours ■ Children under 12 years of age: ask a doctor

Warnings 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 ■ taken with other drugs containing acetaminophen ■ adult has 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. 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 are allergic to acetaminophen ■ with other products 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if ■ any new symptoms occur ■ painful area is red or swollen ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days These could be signs of a serious skin condition Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children 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.

What is SED-MAX used for?
Uses temporary relief of minor aches and pains due to: ■ headache ■ muscular aches

Who makes SED-MAX?
Command Brands, LLC is the labeler of record for SED-MAX.

What form does SED-MAX 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 SED-MAX 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.

Has SED-MAX 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.