ASPIRIN 325 MG- aspirin tablet

Aspirin 325 mg by

Drug Labeling and Warnings

Aspirin 325 mg by is a Otc medication manufactured, distributed, or labeled by WALGREENS, TIME CAP LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose
Pain reliever

INDICATIONS & USAGE

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

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

Do not use:
If you have ever had an allergic reaction to any other pain reliever/fever reducer.

ASK DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis.

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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 INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN 325 MG 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-6453
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
STARCH, CORN (UNII: O8232NY3SJ)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-6453-53	500 in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2022

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	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(0363-6453)