vanquish digital headache

Manufacturer
DSE Healthcare Solutions, LLC | Contract Pharmacal Corporation
Effective date
2020-12-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:01:04

Label at a glance#

Productvanquish digital headache
Active ingredientAcetaminophen, Aspirin, Caffeine
Label structure11 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 194 mg, Aspirin 227 mg, Caffeine 33 mg

OTC - PURPOSE SECTION

Purpose

OTC - PURPOSE SECTION

Pain Reliever, Pain Reliever, Pain Reliever Aid

INDICATIONS & USAGE SECTION

Uses temporarily relieves minor pain due to 

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

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Allergy alert:

Aspirin may cause a severe allergic reaction which may include: hives, facial swelling, asthma (wheezing), and shock.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters and rash. If a skin reaction occurs, stop use and seek medical help right away.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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

OTC - DO NOT USE SECTION

  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 SECTION

If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MADE IN USA

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

Digital Headache™ brand pain reliever

VANQUISH®

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

75 Analgesic COATED CAPLETS

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


11-2203A

EXPIRES         82-375210        Rev 4/20     11042-03-17

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42364-012242364-0122-3, 42364-0122-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c1d13576-080f-4295-af77-595551c3dbb93bad642b-a65c-4d9b-add7-846c23e8dcdc2022-12-23WarningsExact identifier
spl set id: 3bad642b-a65c-4d9b-add7-846c23e8dcdc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.