VANQUISH DIGITAL HEADACHE- acetaminophen, aspirin, and caffeine tablet, coated 
DSE Healthcare Solutions, LLC

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.

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Vanquish Digital Headache

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 194 mg, Aspirin 227 mg, Caffeine 33 mg

Purpose

Pain Reliever, Pain Reliever, 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), 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.

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 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

  • 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

  • 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.

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.

Inactive ingredients

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

Questions or comments?

1-800-214-2379  or www.vanquishheadacherelief.com 

www.dsehealth.com

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.

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

label
VANQUISH DIGITAL HEADACHE 
acetaminophen, aspirin, and caffeine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42364-0122
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:42364-0122-375 in 1 BOTTLE; Type 0: Not a Combination Product03/01/202002/28/2022
2NDC:42364-0122-6100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/202002/28/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/01/202002/28/2022
Labeler - DSE Healthcare Solutions, LLC (603016069)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corporation057795122MANUFACTURE(42364-0122)

Revised: 12/2022
 
DSE Healthcare Solutions, LLC