ECOTRIN REGULAR STRENGTH- aspirin tablet, coated

Ecotrin Regular Strength by

Drug Labeling and Warnings

Ecotrin Regular Strength by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

(in each tablet)

Aspirin (NSAID*) 325mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• temporarily relieves minor aches and pains due to:
  ▪ minor arthritis pain
  ▪ headache
  ▪ toothache
  ▪ menstrual pain
  ▪ muscle pain
  ▪ colds
  
• or as recommended by a doctor

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
  
• shock
  
• facial swelling
  
• asthma (wheezing)

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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

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

• diabetes
  
• gout
  
• arthritis

Stop use and ask a doctor if

• 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
  
• any new symptoms appear
  
• ringing in the ears or a loss of hearing occurs

These could 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 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 of age and over: take 1 to 2 tablets every 4 hours while symptoms last
  ▪ do not take more than 12 tablets in 24 hours unless directed by a doctor
  
• children under 12 years of age: ask a doctor

Other information

• store at 25ºC (77ºF) excursions permitted between 15°-30°C (59°-86°F)
  
• see end flap for expiration date and lot number

Inactive ingredients

black iron oxide, cellulose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

1-800-255-5202 Ecotrin.com

PRINCIPAL DISPLAY PANEL

Ecotrin®
Safety Coated Aspirin
(NSAID) Pain Reliever
325 mg Regular Strength

125 Tablets

INGREDIENTS AND APPEARANCE

ECOTRIN REGULAR STRENGTH 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-302
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETIC ACID (UNII: 9G34HU7RV0)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	Ecotrin;Reg
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-302-01	1 in 1 CARTON	06/01/2012
1		300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 63029-302-02	1 in 1 BOX	06/01/2012
2		125 in 1 BOTTLE, PLASTIC; 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	06/01/2012

Labeler - Medtech Products Inc. (122715688)