Aspirin
FDA Label NDC 12634-120

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotheca, Inc for the product Aspirin (NDC 12634-120). 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 active ingredient, purpose, keep out of reach of children, uses, warnings, dosage & administration, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Each tablet contains Aspirin 325 mg
Aspirin (Acetysalicylic Acid) 325 mg (5gr.) (NSAID)*

Purpose

Pain Reliever

Uses:

For the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor.

Keep Out Of Reach Of Children

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

Uses

Provides temporary relief of

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

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, shock, asthma (wheezing)

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.

Dosage & Administration

Drink a full glass of water with each dose

Adults and children 12 years 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.

Children under 12 years: consult a doctor

Principal Display Panel

MANUFACTURED BY:

Time-Cap Labs, Inc

Farmingdale, NY 11735

Repackaged & Relabeled by:

Apotheca, Inc

Phoenix, AZ 85006

Repackaged & Relabeled for:

RejuviLife

Phoenix, AZ 85006

NDC 12634-120-74

ASPIRIN

ANALGESIC

PAIN RELIEVER

REJUVILIFE

24 TABLETS

325 MG (5 GR EACH)

* Please review the disclaimer below.