Label: CITRAMON- aspirin acetaminophen caffeine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 24, 2016

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  • Active ingredients

    One tablet contains: Aspirin - 220 mg, Acetaminophen - 200 mg, Caffeine - 27 mg.

  • Purpose

    Analgetic - antipyretic

  • Uses

    Effective in mild to moderate intensity pain (including headache, migraine, toothache, pain in osteoarthritis, arthritis, menalgia, algodismenorrhea, lumbago, sciatica, osteochondrosis, neuralgia, myalgia) and fever syndrome in acute infectious, infectious inflammatory diseases.

  • Warnings

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

    Prompt medical attention is critical even if you do not notice any signs or symptons.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control center immediately.

  • Directions

    Adults and children over 15 years take 1 tablet 2 - 3 times a day. The interval between the drug intakes should be at least 6 - 8 hours. Maximum single dose is 2 tablets, maximum daily dose is 4 tablets.

  • Other information

    Keep in a dry place at temperature below 77 ºF (25 ºC).

  • Inactive ingredients

    Cocoa, Citric acid monohydrate, Potato starch, Talc, Stearic acid.

  • PRINCIPAL DISPLAY PANEL

    image of paper blisterimage of group label

  • INGREDIENTS AND APPEARANCE
    CITRAMON 
    aspirin acetaminophen caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16638-118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN220 mg  in 550 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN200 mg  in 550 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE27 mg  in 550 mg
    Inactive Ingredients
    Ingredient NameStrength
    COCOA (UNII: D9108TZ9KG) 22.5 mg  in 550 mg
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 4.6 mg  in 550 mg
    STARCH, POTATO (UNII: 8I089SAH3T) 68 mg  in 550 mg
    TALC (UNII: 7SEV7J4R1U) 2.4 mg  in 550 mg
    STEARIC ACID (UNII: 4ELV7Z65AP) 7.15 mg  in 550 mg
    Product Characteristics
    Colorbrown (Light brown with white inclusions) Score2 pieces
    ShapeROUND (Tablet) Size12mm
    FlavorCOFFEE (Coffee flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16638-118-133300 mg in 1 PACKAGE; Type 0: Not a Combination Product09/11/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/26/1996
    Labeler - Borisovskiy Zavod Medicinskikh Preparatov JSC (628149593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Borisovskiy Zavod Medicinskikh Preparatov JSC628149593manufacture(16638-118)
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