Aspirin 81mg: Package Insert and Label Information

ASPIRIN 81MG- aspirin tablet
Strive Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Aspirin 81mg (NSAID)

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

* 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

* 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.

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.

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.

Pain reliever

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

* avoid excessive heat, cold and humidity.

* close cap tightly after use.

aspirin
(click image for full-size original)

ASPIRIN 81MG
aspirin 81mg tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-158
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
TRIETHYL CITRATE
SILICON DIOXIDE
FD&C YELLOW NO. 6 (FOOD YELLOW 3 FREE ACID)
D&C YELLOW NO. 10
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
STEARIC ACID
TALC
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM (CROSCARMELLOSE)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70692-158-01 100 TABLET in 1 BOTTLE None
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)

Revised: 11/2020 Strive Pharmaceuticals Inc.

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