Active Ingredient(S)
Acetaminophen 500mg
Caffeine 65mg
Sed-max Tablet, Coated
FDA Label NDC 69197-029
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Command Brands, Llc for the product Sed-max (NDC 69197-029). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Pain reliever aid
Uses
temporary relief of minor aches and pains due to:
■ headache
■ muscular aches
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
the user is taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
■ symptoms do not improve
■ pain gets worse or lasts more than 10 days
■ pain gets worse or lasts more than 5 days in children under 12 years
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
■ a rare sensitivity reaction occurs
■ You may report side effects to 1-888-952-0050
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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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
■ do not take 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
Other Information
■ store at room temperature
■ do not use if imprinted safety seal under cap is broken or missing
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.
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