ASPIRIN EXTRA STRENGTH- aspirin tablet, coated

ASPIRIN by

Drug Labeling and Warnings

ASPIRIN by is a Otc medication manufactured, distributed, or labeled by Time-Cap Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 painful 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 cause 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

STORAGE AND HANDLING

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

corn starch, croscarmellose, hypromellose, microcrystalline cellulose,mineral oil, titanium dioxide

INDICATIONS & USAGE

Use for the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor

PURPOSE

Pain Reliever/fever reducer

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, asthmaaa9wheezing)

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.

ACTIVE INGREDIENT

In each Tablet Asprin 500 mg (NSAID*) *non-steroidal anti-inflammatory drug

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN  EXTRA STRENGTH
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49483-382
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	500 mg  in 500

Inactive Ingredients
Ingredient Name	Strength
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	TCL382
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49483-382-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2018
2	NDC: 49483-382-00	100000 in 1 CARTON; Type 0: Not a Combination Product	12/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	02/11/2013

Labeler - Time-Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time-Cap Labs, Inc		037052099	manufacture(49483-382)