Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9df22d80-f368-4ec8-9f39-ff97243d2522
Route
ORAL
Published
Effective Date 2019-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose, Unspecified Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Cellulose, Microcrystalline Silicon Dioxide Sodium Bicarbonate Sodium Lauryl Sulfate Starch, Corn Stearic Acid Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: PH024 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-06-28

Description

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

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

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

Uses
  • temporarily relieves minor aches and pains due to • minor arthritis pains • headache • toothache • menstrual pain • muscle pain • colds
  • or as recommended by a doctor
Section 51945-4

PHARBEST

NDC 73057-357-11

Manufactured in the USA

ARTHRITIS PAIN*

Compare to the active ingredient in Ecotrin®

Safety Coated

Aspirin 325mg

Regular Strength

PAIN RELIEVER (NSAID)

1000 ENTERIC COATED TABLETS

*for the temporary relief of minor Arthritis Pain

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)
  • shock

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
Directions
  • drink a full glass of water with each dose
 adults and children 12 years and over  take 1 to 2 tablets every 4 hours not exceed 12 tablets in 24 hours unless diretced by a doctor
 children under 12 years  ask a doctor

Do Not Use

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

Other Information
  • store at 20-25°C (68-77°F)
  • avoid excess heat and moisture
Inactive Ingredients

croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

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
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 
  • new symptoms occur 
  • ringing in the ears or loss of hearing occurs 

 These could be signs of a serious condition.

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 (1-800-222-1222).

Active Ingredient (in Each Tablet)

Aspirin 325mg (NSAID)

nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to • minor arthritis pains • headache • toothache • menstrual pain • muscle pain • colds
  • or as recommended by a doctor
Section 51945-4 (51945-4)

PHARBEST

NDC 73057-357-11

Manufactured in the USA

ARTHRITIS PAIN*

Compare to the active ingredient in Ecotrin®

Safety Coated

Aspirin 325mg

Regular Strength

PAIN RELIEVER (NSAID)

1000 ENTERIC COATED TABLETS

*for the temporary relief of minor Arthritis Pain

Purpose

Pain reliever

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)
  • shock

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
Directions
  • drink a full glass of water with each dose
 adults and children 12 years and over  take 1 to 2 tablets every 4 hours not exceed 12 tablets in 24 hours unless diretced by a doctor
 children under 12 years  ask a doctor

Do Not Use (Do not use)

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

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excess heat and moisture
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)

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
  • you have asthma
Stop Use and Ask A Doctor If (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 
  • new symptoms occur 
  • ringing in the ears or loss of hearing occurs 

 These could be signs of a serious condition.

If Pregnant Or Breast Feeding (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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

Aspirin 325mg (NSAID)

nonsteroidal anti-inflammatory drug

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

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)