ASPIRIN EC- aspirin tablet, delayed release

Aspirin EC by

Drug Labeling and Warnings

Aspirin EC by is a Otc medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet):

Aspirin 81mg (NSAID)* ...........Pain reliever

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

INDICATIONS & USAGE

• for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
• ask your doctor about other uses for this product.
  

WARNINGS

Reye's syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this products. 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
• asthma (wheezing)
• facial swelling
• 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 have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

• the 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:

• gout
• diabetes
• arthritis
  

Stop use and ask a doctor if:

• 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
• allergic reaction occurs
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• any new symptoms occur
• ringing in the ears or 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 accidental overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222.

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 while symptoms persist. Do not to exceed 48 tablets in 24 hors or as directed by a physician
• children under 12 years: consult a physician
  

16 HOW SUPPLIED/ STORAGE AND HANDLING

Aspirin EC are available in 81 mg tablets as follows:

81 mg tablet: White, round, uncoated tablets with beveled edges debossed with ‘PH023’ on one side, available in:

NDC: 43063-862-90 Bottles of 90

Other information

• Tamper Evident: Do not use if safety seal under cap is broken or missing
• store at room temperature (15°-30°C / 59° -86°F)
• avoid excess heat and moisture
  

Inactive ingredients: crosscarmellose Sodium, D&C yellow# 10 Lake, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.

Questions?

Adverse drug event call: (866) 562-2756 Mon-Fri 8AM to 4PM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN EC 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43063-862(NDC:16103-356)
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow (YELLOW COLOR)	Score	no score
Shape	ROUND (ROUND TABLET)	Size	8mm
Flavor		Imprint Code	PH023
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43063-862-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	01/12/2007

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack(43063-862)