Aspirin 81: Package Insert and Label Information

ASPIRIN 81- aspirin tablet
WALGREENS

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.

DRUG FACTS

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

Purpose
Pain reliever

Uses

• temporarily relieves minor aches and pains

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

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.

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 information

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

Inactive ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, triethyl citrate

Questions or comments? Call 1-877-290-4008

482R-WG-Aspirin-label-500s
(click image for full-size original)

ASPIRIN 81 aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6452
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
SILICON DIOXIDE
DIMETHICONE
STARCH, CORN
ANHYDROUS LACTOSE
CARNAUBA WAX
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW
POLYSORBATE 80
FD&C RED NO. 4
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
TALC
TRIETHYL CITRATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color pink (Peach Colored tablets) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-6452-50 500 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 06/15/2022
Labeler — WALGREENS (008965063)
Registrant — TIME CAP LABORATORIES, INC. (037052099)
Establishment
Name Address ID/FEI Operations
TIME CAP LABORATORIES, INC. 037052099 manufacture (0363-6452)

Revised: 05/2022 WALGREENS

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