ASPIRIN tablet, delayed release

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by America Medic & Science, LLC, Time Cap Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Aspirin Delayed Release Tablets, USP 81 MG Low Dose Safety Coated Aspirin

Drug Facts

Active Ingredient

Aspirin 81 mg (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 release action, this product will not provide fast relief of headaches or other sypmtoms needing immediate relief.

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:

• facial swelling
• asthma (wheezing)
• shock
• hives

WARNINGS

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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

Do not use if you are allergic to aspirin or any other pain reliever/ fever reducer.

ASK DOCTOR

Ask your doctor before use

• 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, kidney disease or asthma
• you are taking a diuretic

ASK DOCTOR/PHARMACIST

Ask your doctor or pharmacist before use if you are taking a prescription drug for

• gout
• diabetes
• arthritis

STOP USE

Stop use and ask 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
• redness or swelling is present
• new symptoms occur
• ringing in the ears or a loss of hearing occurs

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 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.

DO NOT USE

Do not use this product if printed safety seal under cap is torn or missing.

ASK DOCTOR

Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen.

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
• children under 12 years: consult a doctor.

Other information

• save carton for full directions and warnings
• store at room temperature

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Yellow # 10 al lake, FD&C Yellow # 6 al lake, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl citrate

SPL UNCLASSIFIED SECTION

Questions or comments?

call 1-855-314-1850

Aspirin Delayed Release Tablets, USP 81 MG

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49638-115
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
METHACRYLIC ACID (UNII: 1CS02G8656)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49638-115-60	1 in 1 CARTON	03/15/2019
1		60 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 final	part343	03/15/2019

Labeler - America Medic & Science, LLC (071065464)

Registrant - America Medic & Science, LLC (071065464)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Laboratories, Inc		037052099	manufacture(49638-115)