LOW DOSE ASPIRIN- aspirin tablet, delayed release

Low Dose Aspirin by

Drug Labeling and Warnings

Low Dose Aspirin by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet) Aspirin 81 mg (NSAID)nonsterodial anti-inflammatory drug

Purpose Pain reliever

Uses

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reyes 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 olderHave had stomach ulcers or bleeding problemsTake a blood thinning (Anticogulant) or steroid drugTake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day using this product

Do not Use if you are allergic to aspirin or any other pain reliever/fever reducerif 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 ahistory of stomach problems such as heart burnyou have blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic, you have asthama

Ask a doctor or pharmacist before use if you are 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, vomt blood, have bloody or black stools, have stomach pain that does not get better, pain get worse or lasts more than 10 days, fever gets worse or lasts more than 3 daysredness or swelling is present, new symptons occurringing in the ears or a loss of hearing occurs.

If pregnant or breast-feeding ask ahealth professional before use. it is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it my 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 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 not to exceed 48 tablets in 24 hours unless directed by a doctor

Other information

Store at room temparature. Avoid excessive heat above 40°C (104 °F) 

Inactive ingredients

acrycoat, colloidal silicon dioxide, croscarmellose sodium, D&C yellow # 10, Lactose, microcrystalline cellulose, polysorbate 80,

sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow oxide of iron 

Questions or Comments

1-888-333-9792

Principal Display

INGREDIENTS AND APPEARANCE

LOW DOSE ASPIRIN 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-5029
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
METHACRYLIC ACID (UNII: 1CS02G8656)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	81
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-5029-4	1 in 1 CARTON	12/14/2023
1		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/14/2023

Labeler - Spirit Pharmaceuticals LLC (179621011)