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Vanquish

MOBERG PHARMA NORTH AMERICA LLC

Vanquish


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Purpose

Active ingredients
(in each caplet)
Purposes
Acetaminophen 194 mg Pain reliever
Aspirin 227 mg (NSAID)nonsteroidal anti-inflammatory drug Pain reliever
Caffeine 33 mg Pain reliever aid

temporarily relieves minor pain due to

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

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

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • 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

  • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/ fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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
  • fever gets worse or lasts more than 3 days
  • ringing in the ears or loss of hearing occurs
  • new symptoms occur

 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

Vanquish Other information

  • each caplet contains: magnesium 20 mg
  • save carton for full directions and warnings
  • store at room temperature
  • buffered with aluminum hydroxide and magnesium hydroxide

colloidal silicon dioxide, corn starch, croscarmellose sodium, dried aluminum hydroxide gel, hypromellose, magnesium hydroxide, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide, zinc stearate

Questions or comments?

1-877-674-3475

www.vanquishheadacherelief.com

®TM ©2014

Dist. by Moberg Pharma North America LLC
7 E. Frederick Place, Suite 100
Cedar Knolls, NJ 07927

All Rights Reserved. Made in USA.

Principal Display Panel

MADE IN USA

Effective Headache Relief

VANQUISH®

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

82-2201-01

Vanquish

Acetaminophen, Aspirin, and Caffeine TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16864-201
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 194 mg
aspirin ASPIRIN 227 mg
CAFFEINE 33 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
aluminum hydroxide
HYPROMELLOSES
magnesium hydroxide
cellulose, microcrystalline
POVIDONES
propylene glycol
STEARIC ACID
titanium dioxide
ZINC STEARATE

Product Characteristics

Color Size Imprint Code Shape
BLUE 21 mm L374 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:16864-201-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075794 2012-06-26


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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