ASPIRIN REGULAR STRENGTH- aspirin 325mg tablet

Aspirin Regular Strength by

Drug Labeling and Warnings

Aspirin Regular Strength by is a Otc medication manufactured, distributed, or labeled by Ulai Health LLC, Pharbest Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Aspirin 325mg (NSAID)†

†nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• muscle pain
• toothache
• menstrual pain
• colds
• minor pains of arthritis
• temporarily reduces fever

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 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 are allergic to aspirin or any other pain reliever/fever reducer
• if you have ever had an allergic reaction to this product or any of its ingredients

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 a doctor or pharmacist before use if you are

taking a prescription drug for

• gout
• diabetes
• arthritis

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• 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
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• ringing in the ears or loss of hearing occurs
• new symptoms occur

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 (1-800-222-1222).

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 or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

• store at 20-25°C (68-77°F)
• avoid excess heat and moisture

Inactive ingredient

corn starch

Questions or comments?

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PRINCIPAL DISPLAY PANEL

PHARBEST

NDC: 73057-365-11

Manufactured in the USA

*Compare to the active ingredient in Genuine Bayer® Aspirin

Aspirin

Regular Strength

Pain Reliever/Fever Reducer (NSAID)

1000 TABLETS

Aspirin, 325 mg each

INGREDIENTS AND APPEARANCE

ASPIRIN REGULAR STRENGTH 
aspirin 325mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73057-365
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)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (ROUND TABLET)	Size	10mm
Flavor		Imprint Code	PH033
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73057-365-11	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/28/2019
2	NDC: 73057-365-08	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	06/28/2019

Labeler - Ulai Health LLC (081181535)

Registrant - Pharbest Pharmaceuticals, Inc (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceuticals, Inc		557054835	manufacture(73057-365) , analysis(73057-365) , pack(73057-365) , label(73057-365)