Extra Strength Aspirin 325 mg
1d4fbc45-ef89-45ab-bc6d-41f30b468ac7
HUMAN OTC DRUG LABEL
Sep 12, 2025
HealthLife of USA LLC
DUNS: 079656178
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aspirin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
temporary relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever/Fever reducer
WARNINGS SECTION
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
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if
- you have asthma
- 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
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking any other drug or are under a doctor's care for any serious condition
Stop use and ask a doctor if
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 for more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
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 (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
*do not take more than directed
- drink a full glass of water with each dose
*adults and children 12 years of age and over:
• take 1 to 2 tablets every 4 hours while symptoms last
• do not take more than 12 tablets in 24 hours unless directed by a doctor
• do not use for more than 10 days unless directed by a doctor
***children under 12 years:**do not use unless directed by a doctor
STORAGE AND HANDLING SECTION
Other information
- store at controlled room temperature 25ºC (77ºF) execursion permitted between 15-30ºC (59-86ºF) *TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
INACTIVE INGREDIENT SECTION
Inactive ingredients
Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Methylcellulose, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Talc, Titanium Dioxide
OTC - QUESTIONS SECTION
Questions or comments?
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