Aspirin 325 Mg: Package Insert and Label Information

ASPIRIN 325 MG- 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 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose
Pain reliever

Uses
• For the temporary relief of minor aches and pains due to:
o headache
o toothache
o muscle pain
o minor arthritis pain
o menstrual pain
o colds
• or as recommended by a doctor

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 thinner (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 have ever had an allergic reaction to 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 diabetes, gout, or arthritis.

Stop use and ask a doctor if:
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
  • an allergic reaction occurs

Seek medical help right away if:

  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

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 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 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor.
  • children under 12 years: ask a doctor.

Other information
each tablet contains: sodium 1 mg (VERY LOW SODIUM)
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
• use by expiration date on package

Inactive ingredients corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD & C yellow #6 aluminum lake, hypromellose, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

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

331R-WG-Aspirin325-label-500s
(click image for full-size original)

ASPIRIN 325 MG aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6453
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10 ALUMINUM LAKE
HYPROMELLOSE, UNSPECIFIED
MINERAL OIL
POLYSORBATE 80
CROSCARMELLOSE SODIUM
MICROCRYSTALLINE CELLULOSE
DIMETHICONE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
SODIUM HYDROXIDE
TRIETHYL CITRATE
STARCH, CORN
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
TALC
Product Characteristics
Color orange Score no score
Shape ROUND Size 10mm
Flavor Imprint Code T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-6453-53 500 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 (0363-6453)

Revised: 05/2022 WALGREENS

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