ENTERIC COATED ASPIRIN- aspirin tablet

ENTERIC COATED ASPIRIN by

Drug Labeling and Warnings

ENTERIC COATED ASPIRIN by is a Otc medication manufactured, distributed, or labeled by Magno-Humphries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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 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 any other pain reliever/fever reducer  if you have ever had an allergic reaction to this or product or any of its ingredients

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 are taking a diuretic  you have asthma

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  vomit blood  have bloody or black stools  have stomach pain that does not get better  pain gets worse or lasts more than 10 days  fever gets worse or lasts more than 3 days  redness or swelling is present  new symptoms occur  ringing in the ears or a loss of hearing occurs

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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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   children under 12 years: consult a doctor

Other information

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

Inactive ingredients

corn starch, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate. 

Questions?

call toll-free 1-800-935-6737

Package Labeling: 54257-274-25

Package Labeling: 54257-274-06

INGREDIENTS AND APPEARANCE

ENTERIC COATED ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54257-274
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHACRYLIC ACID (UNII: 1CS02G8656)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	L
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54257-274-25	120 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020
2	NDC: 54257-274-06	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/16/2020

Labeler - Magno-Humphries, Inc. (063251433)