ASPIRIN 325 MG EC- aspirin tablet

ASPIRIN 325 MG EC by

Drug Labeling and Warnings

ASPIRIN 325 MG EC by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Aspirin USP, 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain Reliever/Fever Reducer

INDICATIONS & USAGE

temporarily relieves

• headache
• menstrual pain
• minor pain of arthritis
• muscle pain
• toothache
• pain and fever of colds

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 prodcut, 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.

OTHER SAFETY INFORMATION

Allergy alert: Aspirin may cause a severe allergic reaction which may include

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

OTHER SAFETY INFORMATION

Stomach bleeding warning: This prodcut 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 (ibuprofen, naproxen, or others)
• take more or for a longer time than directed
• have 3 or more alcoholic drinks every day while using this product

Drug Facts continued on back of label

DO NOT USE

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

ASK DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout or arthritis
• under a doctor's care for any serious condition
• taking any other drug

STOP USE

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

• pain gets worse or lasts more than 10 days
• fever gets worse or lasta more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear
• ringing in the ears or loss of hearing occurs

These could be sings of a serious condition

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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

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: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

• store at room temperature 15°-30ºC (59°-86°F)

Inactive ingredients

croscarmellose sodium, D&C yellow #10 (Al-lake), FD&C yellow #6 (Al-lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions or comments?

Questions or comments ? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Ecotrin®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Repackaged by: Proficient Rx LP. Thousand Oaks, CA 91320

www.reliable1labs.com

PRINCIPAL DISPLAY PANEL

NDC: 71205-318-60

Enteric Coated

Aspirin USP 325 mg (NSAID)

PAIN RELIEVER

FEVER REDUCER

60 TABLETS

*Compare to Active Ingredients in Ecotrin®

INGREDIENTS AND APPEARANCE

ASPIRIN 325 MG EC 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-318(NDC:69618-015)
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
METHACRYLIC ACID (UNII: 1CS02G8656)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AP;110
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-318-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2019
2	NDC: 71205-318-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2019
3	NDC: 71205-318-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	11/01/2015

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079502574	REPACK(71205-318) , RELABEL(71205-318)