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Aspirin by Velocity Pharma

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: Velocity Pharma
NDC Code: 76168-009

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.

ASPIRIN 81mg

Active Ingredient

(in each tablet)

Aspirin 81 mg (NSAID)

Purpose

Pain Relief

Uses
  • temporarily relieves minor aches and pains

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
  • Asthma (wheezing)
  • Shock
  • Facial Swelling

    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 other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
  • have 3 or more alcoholic drinks every day while using this product
  • takes more or for a longer time than directed

    Do not use

  • if you have ever had an allergic reaction to any pain reliever or fever reducer.

    Ask a doctor before use if:

  • The stomach bleeding warning applies to you
  • You have history of stomach problems such as heartburn
  • You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • You have asthma
  • You are taking a diuretic

    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

  • you experiences any of the following signs of stomach bleeding:
  • feels faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • New symptoms occur
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs

    These could be signs of serious conditions.

    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.

Directions

Adults and Children 12 years and over:

For temporary relief of minor aches and pains, take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours unless directed by a doctor.

Children under 12 years of age: Do not use unless directed by a doctor.

Other Information
  • Store at a controlled temperature between 62 and 77 degrees F

Inactive Ingredients

Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

Questions?

Call 1-855-314-1850

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Velocity Pharma LLC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 76168-009-10 –60 COUNT

Enteric Coated to help prevent upset stomach

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-009
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
ANHYDROUS LACTOSE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
BROWN IRON OXIDE 
METHACRYLIC ACID 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
DIMETHICONE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeA
Contains    
Packaging
#Item CodePackage Description
1NDC:76168-009-1060 CARTON (TABLET) in 1 BOTTLE
11 TABLET (BOTTLE) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/2011
Labeler - Velocity Pharma (962198409)
Registrant - Velocity Pharma (962198409)

 
Velocity Pharma

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Medically reviewed on Oct 23, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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