VANQUISH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, COATED [STRIDES PHARMA INC]

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VANQUISH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, COATED [STRIDES PHARMA INC]
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NDC 59556-810-06, 59556-810-11
Set ID 6511491e-2721-4ec8-bf4a-c36ebfd4a92a
Category HUMAN OTC DRUG LABEL
Packager Strides Pharma Inc
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredients

  • Purpose

    *
    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
  • 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.

    Allergy alert:

    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 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
  • 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 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: (844) 94-RELIEF (844-947-3543)

    www.vanquishheadacherelief.com

    VANQUISH® is a registered trademark of SVADS Holdings SA

    Manufactured for Strides Pharma Inc. East Brunswick, NJ 08816

  • Principal Display Panel

    MADE IN USA

    VANQUISH®

    Effective Headache Relief

    Aspirin (NSAID)/Acetaminophen /Caffeine

    Pain Reliever/Pain Reliever Aid

    100 Analgesic

    COATED CAPLETS

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

    EXPIRES

    82-375210

    Manufactured for Strides Pharma Inc. East Brunswick, NJ 08816

    Vanquish 100s label

    MADE IN USA

    VANQUISH®

    Effective Headache Relief

    Aspirin (NSAID)/Acetaminophen /Caffeine

    Pain Reliever/Pain Reliever Aid

    100 Analgesic

    COATED CAPLETS

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

    EXPIRES

    82-220101

    VANQUISH® is a registered trademark of SVADS Holdings SA

    Manufactured for Strides Pharma Inc. East Brunswick, NJ 08816

    vanquish 100s carton

    MADE IN USA

    VANQUISH®

    Effective Headache Relief

    Aspirin (NSAID)/Acetaminophen /Caffeine

    Pain Reliever/Pain Reliever Aid

    120 Analgesic

    COATED CAPLETS

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

    EXPIRES

    82-375210

    Manufactured for Strides Pharma Inc. East Brunswick, NJ 08816

    Vanquish-120s-label

    -BONUS-

    20% MORE!

    MADE IN USA

    VANQUISH®

    Effective Headache Relief

    Aspirin (NSAID)/Acetaminophen /Caffeine

    Pain Reliever/Pain Reliever Aid

    120 Analgesic

    COATED CAPLETS

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

    EXPIRES

    82-220101

    VANQUISH® is a registered trademark of SVADS Holdings SA

    Manufactured for Strides Pharma Inc. East Brunswick, NJ 08816

    Vanquish 120s carton
  • INGREDIENTS AND APPEARANCE
    VANQUISH 
    acetaminophen, aspirin, and caffeine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-810
    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 (UNII: FZ989GH94E)  
    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 L374
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-810-061 in 1 CARTON06/26/2012
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-810-111 in 1 CARTON06/26/2012
    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 finalpart34306/26/2012
    Labeler - Strides Pharma Inc (078868278)
    Registrant - Strides Pharma Global Pte. Ltd. (659220961)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corporation057795122MANUFACTURE(59556-810)
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