Vanquish Extra Strength Tablet, Coated
FDA Label NDC 42364-2208

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dse Healthcare Solutions, Llc for the product Vanquish Extra Strength (NDC 42364-2208). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, indications & usage, other, do not use, ask a doctor before use if, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Purpose

Active ingredients
(in each caplet)
Purposes
Acetaminophen 250 mg
Pain reliever
Aspirin 250 mg (NSAID)

nonsteroidal anti-inflammatory drug


Pain reliever
Caffeine 65 mg
Pain reliever aid

Indications & Usage

Uses temporarily relieves minor pain due to 

  • headache
  • arthritis
  • backache
  • a cold
  • menstrual cramps
  • muscle aches

Other

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
        • 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

  • 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

Otc - 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

Otc - 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.

Otc - 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

Corn Starch, Hypromellose, Maltodextrin, Medium Chain Triglycerides, Microcrystalline Cellulose, Polydextrose, Povidone K30, Silicon Dioxide, Stearic Acid, Talc, Titanium Dioxide.

Questions Or Comments?

Call: 1-800-214-2379

VANQUISH® is a registered trademark of DSE Healthcare Solutions

Distributed by DSE Healthcare Solutions, LLC.
138 East Main Street, Suite 201, Kent, OH 44240

Principal Display Panel

MADE IN USA 
with Domestic and Imported Ingredients

Extra
Strength


Effective Headache Relief

VANQUISH®
Aspirin (NSAID) / Acetaminophen / Caffeine
Pain Reliever / Pain Reliever Aid

100 Analgesic
COATED CAPLETS

Top Panel

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

Effective Headache Relief

VANQUISH®50 Years of Proven Pain Relief
Refreshed for Today's Digital Lifestyle


LOT:

EXP:

Bottom Panel

Questions or comments?

Call: 1-800-214-2379

VANQUISH®is a registered trademark of DSE Healthcare Solutions
Distributed by DSE Healthcare Solutions, LLC.
138 East Main Street, Suite 201, Kent, OH 44240

R53211

011-2208
09/24

Vanquish 100s Carton (Carton)

Vanquish 100s Carton (Carton)

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

See Carton for Full Information


Questions or Comments?
1-800-214-2379 or www.vanquishheadacherelief.com

www.dsehealth.com

09/24

R53210

Vanquish 100s Label (Label)

Vanquish 100s Label (Label)

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