Aspirin by AiPing Pharmaceutical, Inc. / Anshi Pharmaceutical (Zhongshan) Inc. ASPIRIN tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by AiPing Pharmaceutical, Inc., Anshi Pharmaceutical (Zhongshan) Inc.. 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

Uses

• temporarily relieves minor aches and pains due to:
• headache
• minor arthritis pain
• toothache
• menstrual 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 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

• 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
• redness or swelling is present
• any new symptoms occur
• 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 right away.

Directions

• adults and children 12 years of age and over: take 1 or 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose
• do not take more than 12 tablets in 24 hours unless directed by a doctor
• children under 12 years: ask a doctor.

Other information

• Tamper Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken.
• store below 25ºC (77ºF)

Inactive Ingredients

Pregelatinized starch, microcrystalline cellulose, crospovidone, stearic acid, hypromellose, methacrylic acid copolymer, sodium lauryl sulfate, polysorbate, triethyl citrate, titanium dioxide, talc, FD&C red No.40, FD&C yellow No.5, FD&C yellow No.6, Aluminum Oxide

Questions or comments

Call Toll Free 1-888-952-0050 Monday through Friday 9AM-5PM

Manufactured for:

A&Z Pharmaceutical Inc.
Deer Park, NY 11729

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11788-302
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
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 68401960MK)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
ACRYLIC ACID (UNII: J94PBK7X8S)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11788-302-04	1 in 1 CARTON	01/31/2014
1		40 in 1 BOTTLE; 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	01/31/2014

Labeler - AiPing Pharmaceutical, Inc. (079674526)

Registrant - AiPing Pharmaceutical, Inc. (079674526)

Establishment
Name	Address	ID/FEI	Business Operations
Anshi Pharmaceutical (Zhongshan) Inc.		528101821	manufacture(11788-302) , analysis(11788-302) , label(11788-302) , pack(11788-302)