ASPIRIN 81MG ADULT LOW DOSE- aspirin tablet, delayed release

Aspirin 81mg Adult Low Dose by

Drug Labeling and Warnings

Aspirin 81mg Adult Low Dose by is a Otc medication manufactured, distributed, or labeled by PHARMAMED USA INC, PHARBEST PHARMACEUTICALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Uses

• for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
• ask your doctor about other uses for this product

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 alergic reaction which may include:

• hives
• asthma (wheezing)
• facial sweling
• 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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

• the 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 have asthma
• you are taking a diuretic

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:

• 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
• allergic reaction occurs
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• any new symptoms occur
• ringing in the ears or loss of hearing occurs

These could be signs of a serious condition.

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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• drink a full glass of water with each dose
• adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not to exceed 48 tablets in 24 hours or as directed by a physician
• children under 12 years: consult a physician

Other information

• Tamper Evident: Do not use if the safety seal under the cap is broken or missing
• store at room temperature (15°-30°C)
• avoid excess heat and moisture

Inactive ingredients

croscarmellose sodium, D&C yelow# 10 lake, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.

Questions? Adverse drug event call:

(866) 562-2756

Package Label Principal Display Panel

PHARMAMED

NDC: 84289-356-12

Manufactured in the U.S.A

Pain Reliever (NSAID) / Adult Low Dose

Aspirin

Aspirin 81mg

120 TABS

ENTERIC COATED

Aspirin Regimen

*Compare to the active ingredient in BAYER Low dose

INGREDIENTS AND APPEARANCE

ASPIRIN 81MG ADULT LOW DOSE 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84289-356(NDC:16103-356)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STEARIC ACID (UNII: 4ELV7Z65AP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	PH023
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84289-356-12	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/01/2024

Labeler - PHARMAMED USA INC (065607328)

Registrant - PHARBEST PHARMACEUTICALS, INC. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
PHARBEST PHARMACEUTICALS, INC.		557054835	repack(84289-356)