ADULT LOW DOSE ASPIRIN- aspirin tablet, delayed release

Adult Low Dose Aspirin by

Drug Labeling and Warnings

Adult Low Dose Aspirin by is a Otc medication manufactured, distributed, or labeled by FELICIFIC INC., Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

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 symptoms needing immediate relief.

Warnings

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

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.

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, 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

Storage Conditions

• store at room temperature 20-25ºC (68-77ºF)
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

Starch, Povidone, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl acrylate Co-polymer, Triethyl Citrate, Talc, Fumed Silica, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6.

Questions or comments?

Please contact us at info@heivy.com

Distributed by:

Heivy ®of Felicific Inc

Queens, NY 11435

www.heivy.com

Made in the USA

PRINCIPAL DISPLAY PANEL

NDC: 84014-531-03

Heivy ®

Compare to Bayer ®Low Dose Aspirin active ingredients*

Adult Low Dose Aspirin Delayed Release Tablets, 81 mg

Pain Reliever (NSAID)

Enteric Coated

300 Tablets

*This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer ®Low Dose Aspirin.

INGREDIENTS AND APPEARANCE

ADULT LOW DOSE ASPIRIN 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84014-531
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
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	A1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84014-531-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/01/2024

Labeler - FELICIFIC INC. (081178920)

Establishment
Name	Address	ID/FEI	Business Operations
Health Pharma USA LLC		080804485	manufacture(84014-531)