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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2017

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  • 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)
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