Label: ANA-DENT- acetaminophen, aspirin, 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 7, 2019

If you are a consumer or patient please visit this version.

  • Active ingredients (in each gelcap)

    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID)*
    Caffeine 65 mg
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid

  • Uses

    • temporarily relieves minor aches and pains due to:
      • a cold
      • headache
      • arthritis
      • muscular aches
      • toothache
      • premenstrual and menstrual cramps
  • Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

    • shock
    • facial swelling
    • hives
    • asthma (wheezing)

    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.

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • have had stomach ulcers or bleeding problems
    • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
    • take a blood thinning (anticoagulant) or steroid drug
    • are age 60 or older
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    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 heartbeat.

    Do not use

    • if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have liver disease
    • you have asthma
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for diabetes, gout, or arthritis
    • taking any other drug or are under a doctor’s care for any serious condition

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • ringing in the ears or a loss of hearing occurs
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
    • drink a full glass of water with each dose
    • adults and children 12 years and over
      • take 2 gelcaps every 6 hours
      • do not take more than 8 gelcaps in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • avoid high humidity
    • see end flap for expiration date and lot number
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    corn starch, D&C yellow #10, FD&C blue #1, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, simethicone, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

  • Questions or comments?

    Call 1-888-779-2877 M-F 9AM-5PM EST

  • Principal display panel

    Belmora LLC

    NDC 27854-175-01

    ANA-DENT

    Extra Strength

    Headache Relief

    24 Gelcaps
    Actual Size

    Ingredients for strong relief!

    Acetaminophen 250 mg
    Aspirin (NSAID) 250 mg
    Caffeine 65 mg

    Pain Reliever
    Pain Reliever Aid

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by Belmora LLC, 2011 Crystal Dr. #400, Arlington, VA 22202 www.anadentusa.com

    Distributed by Belmora LLC, 2231 Crystal Dr.,
    Suite 400, Arlington, VA 22202
    www.anadentusa.com

    Ana-Dent 44-571

    Ana-Dent 44-571

  • INGREDIENTS AND APPEARANCE
    ANA-DENT 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-175
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code L;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-175-011 in 1 CARTON09/10/2019
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34309/10/2019
    Labeler - Belmora LLC (112753244)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(27854-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(27854-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(27854-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(27854-175)