MedPath

Low Dose Aspirin

Aspirin Low Dose

Approved
Approval ID

cfe9dc65-dfbb-4c36-a8c9-57bb460a8d97

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

Akron Phama

DUNS: 067878881

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Aspirin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71399-8627
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Aspirin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (17)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)Inactive
Code: T967IEU43C
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
ASPIRINActive
Quantity: 81 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/7/2025

image description

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INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/7/2025

Uses

  • temporarily relief of minor aches and pains or as recommended by your doctor.Because of its delayed release action, this product will not provide fast relieve of headache or symptoms needing immediate relief.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 7/7/2025

Ask a doctor before use if

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 7/7/2025

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • under a doctor's care for any serious condition
  • taking any other drug

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/4/2023

Drug Facts

Active Ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*** nonsteroidal anti-inflammatory drug**

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/7/2025

Purpose****Pain reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 7/7/2025

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 the symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Asiprin may cause a severe allergic reaction, which may include:

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. Ths 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 of nonprescription NSAIDS [aspirin, ibuprofin, 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 you are allergic to aspirin, or any other pain reliever/fever reducer

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/7/2025

Stop use and ask a doctor if

  • 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
  • an allergic reaction occurs. Seek medical help right away.
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more that 10 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling present in the painful area
  • new symptoms occur.

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 7/7/2025

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

LOINC: 50565-1Updated: 7/7/2025

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/7/2025

Directions

  • drink a full glass of water with each dose

*adults and children 12 years and over:

  • take 4 to 8 tablets every 4 hours while symptoms last
  • do not take more than 48 tablets in 24 hours unless directed by a doctor

*children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/7/2025

Other information

  • store at room temperature 15 º-30 ºC(59 º-86 ºF)
  • read all product information before using

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/7/2025

Inactive ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C yellow#10 al lake, FD&C yellow#6 al lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/7/2025

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Low Dose Aspirin - FDA Drug Approval Details