Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 563820a8-c90c-45f2-8af4-a457bb094546

Route

ORAL

Published

Effective Date 2020-01-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Aspirin (325 mg)

Inactive Ingredients

Starch, Corn Povidone

Identifiers & Packaging

Pill Appearance

Imprint: ASPIRIN;1 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2019-12-30

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

temporarily relieves

headache
muscle pain
toothache
menstrual pain
pain and fever of colds
minor pain of arthritis

Section 42229-5

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.

Section 50565-1

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

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug for

gout
diabetes
arthritis

Section 50570-1

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Section 53414-9

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.

Purposes

Pain reliever/fever reducer

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
children under 12 years: consult a doctor

Other Information

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

corn starch, povidone

Questions Or Comments?

Call toll free: 1-800-456-7077

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
- fever lasts more than 3 days
- new symptoms occur
- ringing in the ears or a loss of hearing occurs

Active Ingredient (in Each Tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Principal Display Panel 325 Mg Pouch Label

Safetec

of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.

Buffalo NY 14215

Aspirin Pain Reliever/Fever Reducer

ORIGINAL STRENGTH

2 Tablets

Principal Display Panel – 50 Count Carton Label

Safetec^®

of America, Inc.

*Compare to the active ingredient in

Bayer Genuine Aspirin^®

NDC 61010-4407-1

ORIGINAL STRENGTH

Aspirin

Aspirin 325 mg Pain Reliever/Fever Reducer

PUSH TO OPEN

Dispense

through opening

Relieves minor aches and pains
Fever reducer

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Tablets per Pouch

Principal Display Panel – 100 Count Carton Label

Safetec^®

of America, Inc.

*Compare to the active ingredient in

Bayer Genuine Aspirin^®

NDC 61010-4407-2

ORIGINAL STRENGTH

Aspirin

Aspirin 325 mg – Pain Reliever/Fever Reducer

Relieves minor aches and pains
Fever reducer

PUSH TO OPEN

Dispense

through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Tablets per Pouch

Structured Label Content

Uses

temporarily relieves

headache
muscle pain
toothache
menstrual pain
pain and fever of colds
minor pain of arthritis

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug for

gout
diabetes
arthritis

Section 50570-1 (50570-1)

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Section 53414-9 (53414-9)

Purposes

Pain reliever/fever reducer

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
children under 12 years: consult a doctor

Other Information (Other information)

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

corn starch, povidone

Questions Or Comments? (Questions or comments?)

Call toll free: 1-800-456-7077

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
- fever lasts more than 3 days
- new symptoms occur
- ringing in the ears or a loss of hearing occurs

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

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Principal Display Panel 325 Mg Pouch Label (Principal Display Panel - 325 mg Pouch Label)

Safetec

of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.

Buffalo NY 14215

Aspirin Pain Reliever/Fever Reducer

ORIGINAL STRENGTH

2 Tablets

Principal Display Panel – 50 Count Carton Label

Safetec^®

of America, Inc.

*Compare to the active ingredient in

Bayer Genuine Aspirin^®

NDC 61010-4407-1

ORIGINAL STRENGTH

Aspirin

Aspirin 325 mg Pain Reliever/Fever Reducer

PUSH TO OPEN

Dispense

through opening

Relieves minor aches and pains
Fever reducer

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Tablets per Pouch

Principal Display Panel – 100 Count Carton Label

Safetec^®

of America, Inc.

*Compare to the active ingredient in

Bayer Genuine Aspirin^®

NDC 61010-4407-2

ORIGINAL STRENGTH

Aspirin

Aspirin 325 mg – Pain Reliever/Fever Reducer

Relieves minor aches and pains
Fever reducer

PUSH TO OPEN

Dispense

through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Tablets per Pouch

Advanced Ingredient Data

[{"name": "Aspirin", "unii": "R16CO5Y76E", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "starch, corn", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "povidone", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves headache muscle pain toothache menstrual pain pain and fever of colds minor pain of arthritis", "42229-5": "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.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50568-5": "Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis", "50570-1": "Do not use if you are allergic to aspirin or any other pain reliever/fever reducer", "53414-9": "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.", "Purposes": "Pain reliever/fever reducer", "Directions": "drink a full glass of water with each dose adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours children under 12 years: consult a doctor", "Other information": "store at room temperature 15°-30°C (59°-86°F)", "Inactive ingredients": "corn starch, povidone", "Questions or comments?": "Call toll free: 1-800-456-7077", "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 fever lasts more than 3 days new symptoms occur ringing in the ears or a loss of hearing occurs", "Active ingredient (in each tablet)": "Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug", "Principal Display Panel - 325 mg Pouch Label": "Safetec of America, Inc. DO NOT USE IF POUCH IS TORN OR DAMAGED Manufactured for Safetec of America, Inc. Buffalo NY 14215 Aspirin Pain Reliever/Fever Reducer ORIGINAL STRENGTH 2 Tablets", "Principal Display Panel – 50 Count Carton Label": "Safetec ® of America, Inc. *Compare to the active ingredient in Bayer Genuine Aspirin ® NDC 61010-4407-1 ORIGINAL STRENGTH Aspirin Aspirin 325 mg Pain Reliever/Fever Reducer PUSH TO OPEN Dispense through opening Relieves minor aches and pains Fever reducer TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 50 Pouches 2 Tablets per Pouch", "Principal Display Panel – 100 Count Carton Label": "Safetec ® of America, Inc. *Compare to the active ingredient in Bayer Genuine Aspirin ® NDC 61010-4407-2 ORIGINAL STRENGTH Aspirin Aspirin 325 mg – Pain Reliever/Fever Reducer Relieves minor aches and pains Fever reducer PUSH TO OPEN Dispense through opening TAMPER EVIDENT UNIT DOSE POUCHES DO NOT USE IF POUCH IS TORN OR DAMAGED 100 Pouches 2 Tablets per Pouch"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:02.657410 · Updated: 2026-03-14T22:55:55.934342