Acetaminophen 500 mg with Caffeine 65mg

FDA Drug Profile — SED-MAX

Drug Details

Generic Name
Acetaminophen 500 mg with Caffeine 65mg
Brand Names
SED-MAX
Application Number
M013
Sponsor
Command Brands, LLC
NDC Codes
1
Dosage Forms
TABLET, COATED
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, CAFFEINE

Indications and Usage

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

Warnings

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.