ASPIRIN- aspirin tablet
AiPing Pharmaceutical, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

ASPIRIN
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11788-302
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11788-302-04	1 in 1 CARTON	01/31/2014
1		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	01/31/2014	12/31/2019

Labeler - AiPing Pharmaceutical, Inc. (079674526)

Registrant - AiPing Pharmaceutical, Inc. (079674526)

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

Revised: 5/2021

Document Id: c3294d58-ca1a-c09b-e053-2a95a90ad180

Set id: 5277ba1f-9976-4aa8-941f-00bd87f058fe

Version: 3

Effective Time: 20210525

AiPing Pharmaceutical, Inc.