ASPIRIN by HART Health ASPIRIN tablet

ASPIRIN by

Drug Labeling and Warnings

ASPIRIN by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Aspirin (NSAID)* 325mg (*non-steroidal anti-inflammatory drug)

PURPOSE

Pain Reliever/Fever Reducer

INDICATIONS & USAGE

Uses:

Temporarily relieves minor aches and pains due to:

• headache
• backache
• muscular aches
• minor arthritis pain
• common cold
• toothache
• menstrual cramps

Temporarily reduces fever

WARNINGS

Warnings:

Reye's Syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin

Allergy altert: Aspirin may cause a several 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 ulers or bleeding problems
• take more or for a longer time than directed
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, others)
• have 3 or more alcholic drinks every day while using this product

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 are taking a diuretic
• you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you:

• take any other drug containing an NSAID
• take a blood thinning (anticoagulant) or steroid drug
• take any drug for diabetes, gout, or arthritis

STOP USE

Stop use and ask a doctor if:

• an allergic reaction occurs, seek medical help right away
• fever gets worse or lasts more than 3 days
• pain gets worse or lasts more than 10 days
• redness or swelling is present in the painful area
• ringing in the ears or loss of hearing occurs
• new symptoms occur
• you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

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. 1-800-222-1222

DOSAGE & ADMINISTRATION

Directions:

Do not take more than directed.

Adults and children 12 years of age and over:

• take 1 or 2 tablets with water every 4 hours while symptoms persist
• do not take more than 12 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Microcrystalline Cellulose, Povidone K-30, Starch 1500

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0102
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	TCL011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0102-4	50 in 1 BOX, UNIT-DOSE	06/04/1986
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0102-7	125 in 1 BOX, UNIT-DOSE	06/04/1986
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 50332-0102-8	250 in 1 BOX, UNIT-DOSE	06/04/1986
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 50332-0102-3	25 in 1 BOX, UNIT-DOSE	06/04/1986
4		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	06/04/1986

Labeler - HART Health (069560969)