ASPIRIN- aspirin tablet 325mg tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by WinCo Foods LLC, 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

Purposes
Pain reliever/fever reducer

INDICATIONS & USAGE

Uses
for the temporary relief of minor aches and pains due to
o headache

o colds

o muscle pain
o menstrual pain

o toothache
o minor pain of arthritis
temporarily reduces fever

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
shock
asthma (wheezing)
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 have ever had an 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
you have not been drinking fluids
you have lost a lot of fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are
taking a prescription drug for diabetes, gout, or arthritis
taking any other drug
under a doctor’s care for any serious condition

Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
o feel faint
o have bloody or black stools

o vomit blood
o have stomach pain that does not get better
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear
ringing in the ears or a 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. In case of overdose, get medical help or contact a Poison Control Center 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: consult a doctor

OTHER SAFETY INFORMATION

Other information
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, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

QUESTIONS

Questions? Call 1-800-824-1706 Monday – Friday 9am – 4pm MST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet 325mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-382
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
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MINERAL OIL (UNII: T5L8T28FGP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-382-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2022
2	NDC: 67091-382-30	300 in 1 BOTTLE; Type 0: Not a Combination Product	01/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/18/2022

Labeler - WinCo Foods LLC (056098817)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(67091-382)