Aspirin 81mg by Strive Pharmaceuticals Inc. ASPIRIN 81MG tablet

Aspirin 81mg by

Drug Labeling and Warnings

Aspirin 81mg by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Aspirin 81mg (NSAID)

INACTIVE INGREDIENT

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, methacrylic acid copolymer, microcrytalline cellulose, silicon dioxide, stearic acid, talc, titanium dioxide, triethyl citrate

DOSAGE & ADMINISTRATION

* drink a full glass of water with each dose SEE OVERDOSE WARNING.

• adults and children 12 years of age 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 of age: ask a doctor

INDICATIONS & USAGE

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

*ask your doctor about other uses.

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 everyday 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.\
• If you have ever had an allergic reaction to this product or any of its ingredients.

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
• 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 last more than 10 days
• Redness or swelling is present
• Fever gets worse or last more than 3 days
• 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 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.

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.

PURPOSE

Pain reliever

OTHER SAFETY INFORMATION

* store at room temperature 20 - 25°C (68 - 77°F).

* avoid excessive heat, cold and humidity.

* close cap tightly after use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN 81MG 
aspirin 81mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-158
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-158-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/18/2020

Labeler - Strive Pharmaceuticals Inc. (080028013)