Label: SED-MAX- acetaminophen 500 mg with caffeine 65mg tablet, coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 19, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient(s)

    Acetaminophen 500mg

    Caffeine 65mg

  • 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

    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.

  • 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

  • Other information

    ■ store at 20-25C (68-77F)

    ■ do not use if imprinted safety seal under cap is broken or missing

    ■you may report side effects to 1-888-952-0050

  • 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

  • Principal Display Panel

    Sedmax

    Sedmax

     

  • INGREDIENTS AND APPEARANCE
    SED-MAX 
    acetaminophen 500 mg with caffeine 65mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69197-029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE (UNII: 029TFK992N)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ;029
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69197-029-201 in 1 CARTON11/26/2014
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/26/2014
    Labeler - Command Brands, LLC (060684113)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!