Low Strength Chewable Aspirin

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:40:25

Label at a glance#

ProductLow Strength Chewable Aspirin
Active ingredientASPIRIN
Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Dosage and administration

drink a full glass of water with each dose 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 or as recommended by your doctor

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.
  • this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

  • the 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
  • you have asthma

Ask a doctor or pharmacist before use if you are you
are taking a prescription drug for
 gout diabetes  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 at 20 weeks or later in
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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • 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

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
318272aspirin 81 MG Chewable TabletPSN6
318272aspirin 81 MG Chewable TabletSCD6
318272ASA 81 MG Chewable TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-911-36Low Strength Chewable Aspirin36 in 1 BOTTLETABLET, CHEWABLE366

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-911LOW STRENGTH CHEWABLE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [GERI-CARE PHARMACEUTICAL CORP]6Current NDC, Legacy NDC, 1 package rows20241206_cc77b9d1-7874-4ce8-a763-3a0e1c2891de.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-911-36EA - Each57896-911ed5530ce-fafe-440e-8d00-7d60882aca2712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
ASPIRINACTIVE MOIETYR16CO5Y76E1
DEXTRATESINACTIVE INGREDIENTG263MI44RU1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TY1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1

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
57896-91157896-911-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SACCHARIN SODIUM DIHYDRATESACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DEXTRATESDEXTRATESG263MI44RUTABLET, CHEWABLE / ORAL6398 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Low Strength Chewable AspirinASPIRINGeri-Care Pharmaceutical Corpcc77b9d1-7874-4ce8-a763-3a0e1c2891de2024-12-03WarningsExact identifier
ndc (package): 57896-911-36
ndc (product): 57896-911
ndc11 (package): 57896091136
spl id: 28619a75-956c-f5f6-e063-6294a90ac815
spl set id: cc77b9d1-7874-4ce8-a763-3a0e1c2891de

Reported adverse events (FAERS/openFDA)#

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