ASPIRIN by H-E-B / TIME CAP LABS INC ASPIRIN tablet, coated

ASPIRIN by

Drug Labeling and Warnings

ASPIRIN by is a Otc medication manufactured, distributed, or labeled by H-E-B, TIME CAP LABS 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 AND USAGE

Uses

for the temporary relief of minor aches and pains due to

• headache
• colds
• menstrual pain
• muscle pain
• toothache
• minor pain of arthritis

or as directed by your 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
• 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
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

DO NOT USE

Do not use

• if you are allergic to aspirin or 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 asthma
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have not been drinking fluids
• you have lost a lot of fluid due to vomiting or diarrhea

ASK DOCTOR/PHARMACIST

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

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

• feel faint
• have bloody or black stools
• vomit blood
• 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 painfull area

any new symptoms appear

ringing in the ears or a loss of hearing occurs

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 casue problems in the unborn child or complications during delivery.

KEEP OUT OF REACH OF CHILDREN

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 ingredientscorn starch, croscramellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-174
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

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: 37808-174-73	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2024
2	NDC: 37808-174-32	300 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2024
3	NDC: 37808-174-53	500 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/01/2024

Labeler - H-E-B (007924756)

Registrant - TIME CAP LABS INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABS INC		037052099	manufacture(37808-174)