Aspirin
FDA Label NDC 65437-038

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Himprit Pharmachem Pvt Ltd for the product Aspirin (NDC 65437-038). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purposes, uses, reye's syndrome, allergy alert, alcohol warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Tablet)

Aspirin 325 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves

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

Reye's Syndrome

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy Alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Alcohol Warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Otc - Do Not Use

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

Otc - Ask Doctor

Ask a doctor before use if you have

  • stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
  • bleeding problems
  • ulcers
  • asthma

Otc - Ask Doctor/Pharmacist

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

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

Otc - Stop Use

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • 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 loss of hearing occurs

Otc - Pregnancy 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.

Otc - 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.

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

  • save carton for full directions and warnings
  • store at room temperature

Inactive Ingredients

carnauba wax

may contain this ingredient

, corn starch, hypromellose, powdered cellulose, triacetin

Principal Display Panel

ASPIRIN 325 MG TABLETS
Each Film coated Tablet Contains:
ASPIRIN 325 MG

Lot No :
MFG. DATE :
Exp. Date :
Jar No. :
Quantity : 50,000 Tablets
NDC. No : 65437-038-05

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° –86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

MANUFACTURED BY:
MANUFACTURED CODE No Guj/Drugs/G/1362
LABELER CODE # 14803

MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

Principal Display Panel (Aspirin 01)

Principal Display Panel (Aspirin 01)

* Please review the disclaimer below.