Extra Strength Aspirin

Manufacturer
Healthlife of USA | Time Cap Laboratories, Inc.
Effective date
2021-10-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:33:34

Label at a glance#

ProductExtra Strength Aspirin
Active ingredientASPIRIN
Label structure15 sections

Indications and uses

Temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps

Dosage and administration

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

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Pain reliever/ Fever reducer

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325mg

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

Warnings

WARNINGS SECTION

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 behaviour 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 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

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin, or any other pain reliever/fever reducer

Ask a doctor before use if 

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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:

OTC - STOP USE SECTION

  1. you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better

2.   an allergic reaction occurs.

  • seek medical help right away.

3.   ringing in the ears or loss of hearing occurs

4.   pain gets worse or lasts for more than 3 days

5.   redness or swelling present

6.   new symptoms occur

These could be sign of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not take more than directed
  • Drink a full glass of water with each dose 
  • Adults and children 12 years of age and over: 
  1. take 1 to 2 tablets every 4 hours while symptoms last
  2. do not take more than 12 tablets in 24 hours unless directed by a doctor
  3. 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

Other Information

OTC - WHEN USING SECTION

  • Store at controlled room temperature 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Corn starch
  • Croscarmellose sodium
  • Hypromellose
  • Microcrystalline cellulose
  • Mineral oil
  • Titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST or www.healthlifeofusa.com

Extra Strength Aspirin  Aspirin 325 mg 60 Tablets  Compare to Bayer® EXTRA STRENGTH active ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:
Healthlife of USA LLC
Rahway
NJ 07065
www.healthlifeofusa.com

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-115-602024-10-18C16284748780-1f386c64a-3b9d-0266-e053-dadaa90a7c1aExtra Strength Aspirin
69517-115-602023-01-30C16284748780-1f386c64a-3b9d-0266-e053-dadaa90a7c1aExtra Strength Aspirin

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-11569517-115-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
085b35db-62d3-38db-e063-6394a90a97631118dc27-0a9e-4a48-b86c-1338bf28fecc2024-10-18WarningsExact identifier
spl set id: 1118dc27-0a9e-4a48-b86c-1338bf28fecc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.