Aspirin by Aphena Pharma Solutions - Tennessee, LLC ASPIRIN tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each tablet)

Aspirin 325 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ Fever Reducer

Uses

temporarily relieves

• headache
• menstrual pain
• muscle pain
• toothache
• minor pain or arthritis
• 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 product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early signs of  Reye’s syndrome, a rare but serious illness.

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

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

  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
• takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
• takes more or for a longer time than directed
• have 3 or more alcoholic drinks every day while using this product.

  Do not use

• if you have ever had an allergic reaction to 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, lever 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 or arthritis
• taking any other drug
• under a doctor’s care for any serious condition

  Stop use and ask a doctor if

• you experiences 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 in the painful area
• any new symptoms appear
• 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 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, but not more than 12 tablets in 24 hours.
• Children under 12 years: ask a doctor

Other Information

• avoid excessive heat or humidity
• store at 15-30 °C (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, PVP,  sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide

Questions or Comments

Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday

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

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

• Count: 325mg
• 100: 71610-034-65

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20180218JH

PRINCIPAL DISPLAY PANEL - 325mg

NDC: 71610-034 - Aspirin EC (NSAID) 325mg - Rx Only

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71610-034(NDC:54738-111)
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
METHACRYLIC ACID (UNII: 1CS02G8656)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AP;011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71610-034-65	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	05/01/2015

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-034)