ASPIRIN 81- aspirin tablet

Aspirin 81 by

Drug Labeling and Warnings

Aspirin 81 by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Invahealth Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)#
#nonsteroidal anti-inflammatory drug

PURPOSE

Purpose
Pain reliever

INDICATIONS & USAGE

Uses

temporarily relieves minor aches and pains

ask your doctor about other uses for enteric coated 81 mg Aspirin.

WARNINGS

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

Ask a doctor before use if

• 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 taking a prescription drug for gout, diabetes or arthritis

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• 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

• pain gets worse or lasts more than 10 days
• ringing in the ears or a loss of hearing occurs
• redness or swelling is present
• new symptoms occur. These could be signs 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.

DOSAGE & ADMINISTRATION

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 not to exceed 48 tablets in 24 hours unless directed by a doctor
• children under 12 years: do not use unless directed by a doctor

OTHER SAFETY INFORMATION

Other information

• Store at 20-25°C (68-77°F)
• close cap tightly after use

INACTIVE INGREDIENT

Inactive ingredients

colloidal silicon dioxide, crosscarmellose sodium, D&C yellow#10, FD&C yellow#6, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, talcum, titanium dioxide, triethyl citrate

QUESTIONS

Questions or comments? Call 1-844-474-7464

PRINCIPAL DISPLAY PANEL

Rising Health

Aspirin 81 mg

NDC: 57237-302-10

1000 Tablets

INGREDIENTS AND APPEARANCE

ASPIRIN 81 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-302
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
METHACRYLIC ACID (UNII: 1CS02G8656)
TALC (UNII: 7SEV7J4R1U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	I1;Plain
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-302-12	120 in 1 BOTTLE; Type 0: Not a Combination Product	10/25/2022
2	NDC: 57237-302-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013.50	10/25/2022

Labeler - Rising Pharma Holdings, Inc. (116880195)

Establishment
Name	Address	ID/FEI	Business Operations
Invahealth Inc.		116840615	manufacture(57237-302) , analysis(57237-302) , label(57237-302) , pack(57237-302)