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Vazalore: Package Insert / Prescribing Info

Package insert / product label
Generic name: aspirin
Dosage form: capsule
Drug classes: Platelet aggregation inhibitors, Salicylates

Medically reviewed by Drugs.com. Last updated on Jan 9, 2025.

Indications and Usage for Vazalore

  • For temporary relief of minor aches and pains associated with:
  • headache
  • Backache
  • muscular aches
  • a cold
  • toothache
  • minor pains of arthritis
  • premenstrual and menstrual cramps
  • temporarily redices fever
  • n ask your doctor about other uses of aspirin capsules

Warnings

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

n hives n facial wseelling n shock n astham (wheezing)

This product contains soy

Stomach bleeding warning: This product contains an NSAID, which may cause 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

Active Ingredient (in Each capsules)

Aspirin (NSAID)* 325mg

*Non steroidal Anti inflammatory Drug

Ask a doctor before use if:

  • 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

Do not use If you have ever had an allergic reaction to aspirin or any other pain reliever / fever reducer

Ask a doctor or a pharmacist before you use if you are

  • Taking a drug for diabetes, gout or arthritis

Stop use and ask a doctor

Stop use and ask a doctor if

  • An allergic reaction occurs. Seek medical help right away
  • You experience amu of the following signs of stomach bleeding

- Feel faint - vomit blood - have bloody or black stool - 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
  • Redness and swelling is present in the painful area
  • Any new symptoms occur. These could be signs of serious conditions

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

If pregnant or breast feeding, ask a healthcare 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

Purposes:

Aspirin (NSAID)* 325mg __ Pain reliever / fever reducer

*Non steroidal Anti inflammatory Drug

Questions or Comments

Questions or comments?

Call 1-888-842-3569 9:00 AM – 7:00 PM ET, Monday – Friday

RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION

Storage and Handling

Other Information

  • Save carton for full directions and warnings
  • Store at 15-30°C (59-86°F)
  • Avoid excessive heat above 40°C (104°F)
  • Do not use if the blue band around the capsule is missing or broken

Inactive ingredients

Anhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C blue #1, Hypromellose, lecithin, oleic acid, pharmaceutical ink, potassium chloride, soybean oil, titanium dioxide

Vazalore Dosage and Administration

Directions

  • Drink a full glass of water with each dose
  • Adults and children 12 years and over:
    • Take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist
    • Do not exceed 12 capsules in 24 hours
  • Children under 12 years consult a doctor

30 Count Blister Carton

30 CT Bottle Carton

30 Count Bottle Label

30 CT Bottle Label

4 Count Blister Card

4 ct blister card

4 Count Blister Carton

4 Ct Blister Carton

12 Count Blister Carton

12 Ct Blister Carton

VAZALORE
aspirin capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73089-081
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg in 81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
OLEIC ACID (UNII: 2UMI9U37CP)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SOYBEAN OIL (UNII: 241ATL177A)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Colorwhite (White with Blue Band and A81 Imprint) Scoreno score
ShapeCAPSULE (White Capsule with Blue Band and A81 Imprint) Size14mm
FlavorImprint CodeA81
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73089-081-211 in 1 CARTON08/05/2021
181 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:73089-081-121 in 1 CARTON08/05/2021
281 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:73089-081-1481 mg in 1 CARTON; Type 0: Not a Combination Product08/05/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20369708/05/2021
Labeler - PLx Pharma Inc (079325568)
Registrant - PLx Pharma Inc (079325568)

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