Enteric Coated Aspirin: Package Insert and Label Information

ENTERIC COATED ASPIRIN — aspirin tablet
A-S Medication Solutions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENTS (IN EACH TABLET)

Aspirin 325mg (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 will not provide fast relief of headaches or other symptoms 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:

• 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 other pain relievers/fever reducers

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 have asthma
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for:

• anticoagulation (thinning the blood)
• diabetes
• gout
• 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
• new symptoms occur
• redness or swelling is present
• ringing in the ears or loss of hearing occurs
• pain gets worse or lasts for more than 10 days

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 specifically 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
• adults and children 12 years and over: take 1 or 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
• children under 12 years: consult a doctor

OTHER INFORMATION

• store at room temperature
• do not use if imprinted safety seal under cap is broken or missing

You may report serious side effects to: 1-888-952-0050

INACTIVE INGREDIENTS

corrn starch, croscarmellose sodium, Dimethicone, D&C Yellow # 10 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

Regular Strength

ENTERIC COATED ASPIRIN regular strength tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-0003(NDC:0603-0169) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (ASPIRIN) ASPIRIN 325 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN DIMETHICONE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 TITANIUM DIOXIDE TALC TRIETHYL CITRATE SODIUM HYDROXIDE FD&C YELLOW NO. 6 POLYSORBATE 80 HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A SODIUM LAURYL SULFATE MINERAL OIL

Product Characteristics Color orange Score no score Shape ROUND Size 11mm Flavor Imprint Code T Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50090-0003-1 30 TABLET in 1 BOTTLE None 2 NDC:50090-0003-3 100 TABLET in 1 BOTTLE None 3 NDC:50090-0003-5 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 02/04/2011

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-0003), REPACK (50090-0003)

Revised: 08/2017 A-S Medication Solutions