Enteric Coated Low Dose Aspirin

Manufacturer
Bene Health OTC | Geri-Care Pharmaceutical Corp
Effective date
2021-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:25:03

Label at a glance#

ProductEnteric Coated Low Dose Aspirin
Active ingredientASPIRIN
Label structure8 sections

Indications and uses

for the temporary relief of minor aches and pains ask your doctor about other uses for aspirin

Dosage and administration

drink a full glass of water with each dose swallow whole, do not chew or crush do not exceed recommended dose adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor children under 12 years: ask a doctor

Storage and handling

store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg(NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin

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 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 your are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

  • 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
  • an allergic reaction occurs. Seek medical help right away
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • ringing in the ears or 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • do not exceed recommended dose
  • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cellulose, D &C yellow #10,
FD&C yellow #6, hypromellose, methacrylic acid,
PEG, polydextrose, propylene glycol, silica,
simethicone, sodium bicarbonate, sodium lauryl sulfate,
starch, talc, titanium dioxide, triacetin, triethyl citrate,
wax. May also contain: acetylated monoglycerides,
croscarmellose sodium, hypromellose phthalate,
lactose, mineral oil, polysorbate 80, stearic acid.

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65155-981-12EA - Each65155-9816610102b-c35f-4721-b88d-04b77564d35012020-07-13

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65155-98165155-981-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

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
d22eca5a-309b-a57b-e053-2a95a90ac532a7abf2be-bb8f-6c05-e053-2995a90a04772021-12-02WarningsExact identifier
spl id: d22eca5a-309b-a57b-e053-2a95a90ac532
spl set id: a7abf2be-bb8f-6c05-e053-2995a90a0477

Reported adverse events (FAERS/openFDA)#

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