ADULT LOW DOSE ENTERIC COATED ASPIRIN- aspirin tablet, coated

Adult Low Dose Enteric Coated Aspirin by

Drug Labeling and Warnings

Adult Low Dose Enteric Coated Aspirin by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 81 mg(NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• for the temporary relief of minor aches and pains
• ask your doctor about other uses for aspirin

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 your are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

• the stomach bleeding warning applies to you
• you are taking a diuretic
• you have a history of stomach problems, such as heartburn
• you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

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

These can 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 at 20 weeks or later in 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.

Directions

• drink a full glass of water with each dose
• swallow whole, do not chew or crush
  
• do not exceed recommended dose
• adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
• children under 12 years: ask a doctor

Other information

• store at 20-25°C (68-77°F); excursions permitted between 15°C-30°C (59°F-86°F)

Inactive ingredients

cellulose, croscarmellose sodium, D&C Yellow #10 Lake, lactose monohydrate, methacrylic acid co-polymer, PEG, polacrilin potassium, polyvinyl alcohol, silica, sodium lauryl sulfate, soya powder, talc, titanium dioxide, triethyl citrate

Relabeled By: Preferred Pharmaceuticals Inc.

Questions or comments?

1-800-540-3765

package label

INGREDIENTS AND APPEARANCE

ADULT LOW DOSE ENTERIC COATED ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-8565(NDC:57896-983)
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SOYBEAN (UNII: L7HT8F1ZOD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-8565-8	120 in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/12/2024

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	REPACK(68788-8565)