Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 42313186-9625-4c90-937b-8e9b9f73047a
Route
ORAL
Published
Effective Date 2014-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn Povidones

Identifiers & Packaging

Pill Appearance
Imprint: Aspirin;GPI Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-09-29

Description

Aspirin 325 mg (NSAID)* * nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Aspirin 325 mg (NSAID)* * nonsteroidal anti-inflammatory drug

Uses

for temporary relief of





  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • minor aches and pains
  • temporarily reduces fever
Section 53414-9

, ask a health professional before use. It is especially important not to use Aspirin during 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. If pregnant or breast-feeding

Purposes

Pain reliever/fever reducer

Warnings

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. Reye's syndrome:

Aspirin may cause a severe allergic reaction, which may include Allergy alert:





  • hives

  • facial swelling
  • asthma(wheezing)
  • shock

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning:





  • 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
Directions
  • Drink a full glass of water with each dose
  • Do not take more than directed
  • take 1 to 2 tablets every 4 hours, or 3 tablets every 6 hours as needed. Do not take more than 12 tablets in 24 hours Adults and children 12 years and older:

  • ask a doctor Children under 12:
Do Not Use

with any other product containing Aspirin or if you have ever had an allergic reaction to aspirin or other pain relievers/fever reducers.



Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Other Information
  • Do not use if imprinted safety seal under cap is broken or missing.
  • Store at room temperature

Inactive Ingredients

Corn Starch, Povidone.



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


Stop Use and Ask A Doctor If
  • 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
  • new symptoms occur
  • ringing in the ears or hearing loss occurs
  • redness or swelling is present



Keep Out of Reach of Children.

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



Active Ingredient (in Each Tablet)

Aspirin 325 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Plus Pharma Nsaid 325 Mg (aspirin) Tablet
Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for





  • anticoagulation (blood thinning)
  • gout
  • diabetes
  • arthritis


Structured Label Content

Uses

for temporary relief of





  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • minor aches and pains
  • temporarily reduces fever
Section 53414-9 (53414-9)

, ask a health professional before use. It is especially important not to use Aspirin during 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. If pregnant or breast-feeding

Purposes

Pain reliever/fever reducer

Warnings

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. Reye's syndrome:

Aspirin may cause a severe allergic reaction, which may include Allergy alert:





  • hives

  • facial swelling
  • asthma(wheezing)
  • shock

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning:





  • 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
Directions
  • Drink a full glass of water with each dose
  • Do not take more than directed
  • take 1 to 2 tablets every 4 hours, or 3 tablets every 6 hours as needed. Do not take more than 12 tablets in 24 hours Adults and children 12 years and older:

  • ask a doctor Children under 12:
Do Not Use (Do not use)

with any other product containing Aspirin or if you have ever had an allergic reaction to aspirin or other pain relievers/fever reducers.



Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Other Information (Other information)
  • Do not use if imprinted safety seal under cap is broken or missing.
  • Store at room temperature

Inactive Ingredients (Inactive ingredients)

Corn Starch, Povidone.



Ask A Doctor Before Use If (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


Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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
  • new symptoms occur
  • ringing in the ears or hearing loss occurs
  • redness or swelling is present



Keep Out of Reach of Children. (Keep out of reach of children.)

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



Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 325 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

Plus Pharma Nsaid 325 Mg (aspirin) Tablet (PLUS PHARMA NSAID 325 MG (ASPIRIN) TABLET)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for





  • anticoagulation (blood thinning)
  • gout
  • diabetes
  • arthritis


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)