ADULT LOW DOSE ASPIRIN 81 MG- aspirin tablet, delayed release

Adult Low Dose Aspirin 81 mg by

Drug Labeling and Warnings

Adult Low Dose Aspirin 81 mg by is a Otc medication manufactured, distributed, or labeled by HealthLife of USA LLC, ELYSIUM PHARMACEUTICALS LIMITED, HHH PHARMA USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses:

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

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
• shock
• facial swelling
• 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

Do not use

• if you are allergic to aspirin or any other pain reliever/fever reducer

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

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

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 than 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 sign of a serious condition.

If pregnant 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.

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.

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

Other information

• store at room temperature 15-30ºC (59-86ºF)
• read all product information before using.
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients:

Acrycoat, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow# 10, Yellow Oxide of Iron, Lactose, Microcrystalline Cellulose, Polysorbate 80, Sodium Hydroxide, Talc, Titanium Dioxide, Triethyl Citrate.

Questions or comments?

Call toll free 1 844-832-1138 Monday through Friday 9 AM-5 PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADULT LOW DOSE ASPIRIN 81 MG 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
LACTOSE (UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TALC (UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	A1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-001-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/12/2025
2	NDC: 69517-001-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	09/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	09/12/2025

Labeler - HealthLife of USA LLC (079656178)

Registrant - HealthLife of USA LLC (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		863182240	manufacture(69517-001)

Establishment
Name	Address	ID/FEI	Business Operations
HHH PHARMA USA LLC		062788820	pack(69517-001)