VANQUISH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, COATED [DSE HEALTHCARE SOLUTIONS, LLC]

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VANQUISH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, COATED [DSE HEALTHCARE SOLUTIONS, LLC]
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NDC 42364-0011-1, 42364-0011-2
Set ID f879e8c7-1983-4a85-b87d-38f5068351fc
Category HUMAN OTC DRUG LABEL
Packager DSE Healthcare Solutions, LLC
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredients

    *
    nonsteroidal anti-inflammatory drug
    Active ingredients
    (in each caplet)
    		Purpose
    Acetaminophen 194 mg
    		 Pain reliever
    Aspirin 227 mg (NSAID)*
    		Pain reliever
    Caffeine 33 mg
    		 Pain reliever aid
  • INDICATIONS & USAGE

    Uses temporarily relieves minor pain due to 

    • headache
    • arthritis
    • backache
    • colds
    • menstrual cramps
    • muscle aches
  • 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.

    Aspirin may cause a severe allergic reaction which may include:

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

    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 8 caplets in 24 hours, which is the maximum daily amount for this product
    • 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

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
  • Do not use

    • 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 are allergic to aspirin or any other pain reliever/fever reducer
  • Ask a doctor before use if

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

    Ask a doctor or pharmacist before use if you are taking a prescription drug for 

    • gout
    • diabetes
    • arthritis
  • 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
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • ringing in the ears or loss of hearing occurs
    • new symptoms occur
  • PREGNANCY OR BREAST FEEDING

    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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 the recommended dose
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours unless directed by a doctor
    • children under 12 years: consult a doctor
  • Other information

    • save carton for full directions and warnings
    • store at room temperature
  • Inactive ingredients

    Colloidal Silicon Dioxide, Corn Starch, Hypromellose, Maltodextrin, Microcrystalline Cellulose, Polydextrose, Povidone, Sodium Carboxymethyl Starch, Stearic Acid, Talc, Titanium Dioxide and Triglycerides

    Each tablet contains 0.11 mg. of Sodium

  • Questions or comments?

    Call: 1-800- 214-2379

    www.vanquishheadacherelief.com

    VANQUISH® is a registered trademark of SVADS Holdings SA

    Distributed by DSE Healthcare Solutions, LLC
    27070 Miles Rd, Suite A, Solon, OH 44139

  • Principal Display Panel

    MADE IN USA

    Do not use this product if printed safety seal under cap is torn or missing.

    Effective Headache Relief

    VANQUISH®

    Aspirin (NSAID) / Acetaminophen / Caffeine Pain Reliever / Pain Reliever Aid
    100 Analgesic COATED CAPLETS

    Distributed by DSE Healthcare Solutions, LLC
    27070 Miles Rd, Suite A, Solon OH 44139

    011-2201 L

    EXPIRES         82-375210         11042-03-17

    Vanquish 100s label

    MADE IN USA 
     
    Effective Headache Relief

    VANQUISH®

    Aspirin (NSAID) / Acetaminophen / Caffeine Pain Reliever / Pain Reliever Aid
    100 Analgesic COATED CAPLETS

    VANQUISH® is a registered trademark of SVADS Holdings SA
    Distributed by DSE Healthcare Solutions, LLC
    27070 Miles Rd, Suite A, Solon OH 44139

    www.vanquishheadacherelief.com
     
    EXPIRES

    11043-03-17

    011-2201 C

    vanquish 100s carton

    MADE IN USA

    Do not use this product if printed safety seal under cap is torn or missing.

    Effective Headache Relief

    VANQUISH®

    Aspirin (NSAID) / Acetaminophen / Caffeine Pain Reliever / Pain Reliever Aid
    120 Analgesic COATED CAPLETS

    Distributed by DSE Healthcare Solutions, LLC
    27070 Miles Rd, Suite A, Solon OH 44139

    011-2202 L

    EXPIRES         82-375210         11044-03-17

    Vanquish 120s label

     MADE IN USA 
     
    - BONUS - 20% MORE!
    Effective Headache Relief

    VANQUISH®

    Aspirin (NSAID) / Acetaminophen / Caffeine Pain Reliever / Pain Reliever Aid
    120 Analgesic COATED CAPLETS

    VANQUISH® is a registered trademark of SVADS Holdings SA
    Distributed by DSE Healthcare Solutions, LLC
    27070 Miles Rd, Suite A, Solon OH 44139

    www.vanquishheadacherelief.com
     
    EXPIRES

    11045-03-17

    011-2202 C

    Vanquish 120s carton
  • INGREDIENTS AND APPEARANCE
    VANQUISH 
    acetaminophen, aspirin, and caffeine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42364-0011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen194 mg
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin227 mg
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine33 mg
    Inactive Ingredients
    Ingredient NameStrength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Polydextrose (UNII: VH2XOU12IE)  
    Povidone K30 (UNII: U725QWY32X)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code VANQUISH
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42364-0011-11 in 1 CARTON07/15/2018
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:42364-0011-21 in 1 CARTON07/15/2018
    2120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/15/2018
    Labeler - DSE Healthcare Solutions, LLC (603016069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corporation057795122MANUFACTURE(42364-0011)
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