Sed-max

Acetaminophen 500 mg with Caffeine 65mg · Tablet, Coated · Oral

Over the counter Central Nervous System Stimulant Methylxanthine

Active ingredient

Active ingredient(s) Acetaminophen 500mg Caffeine 65mg

Purpose

Purpose Pain reliever/fever reducer Pain reliever aid

Uses

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.

Do not use

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

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor

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 or breast-feeding

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 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.

Directions

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

Inactive ingredients

Inactive ingredients corn starch, croscarmellose, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Label text from the FDA structured product label by Command Brands, LLC (revised Jan 19, 2017). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Acetaminophen in 1 product
Caffeine in 1 product

Sed-max NDC products (1)

NDC	Strength & form	Labeler	Type
69197-029	Acetaminophen 500 mg/1; Caffeine 65 mg/1 Tablet, Coated	Command Brands, LLC	OTC MONOGRAPH DRUG

Frequently asked questions

What is Sed-max used for?

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

Who makes Sed-max?

Sed-max is listed by 1 labeler in the FDA NDC directory, including Command Brands, LLC.