PHARBEST ASPIRIN 325MG- aspirin tablet, delayed release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
A-S Medication Solutions
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever - temporarily relieves minor aches and pains due to • colds • headache • muscle pain • menstrual pain • minor pains of arthritis • toothache - or as receommended by your doctor
Product summary:
Product: 50090-0004 NDC: 50090-0004-1 30 TABLET, DELAYED RELEASE in a BOTTLE NDC: 50090-0004-3 100 TABLET, DELAYED RELEASE in a BOTTLE NDC: 50090-0004-5 90 TABLET, DELAYED RELEASE in a BOTTLE
Authorization status:
OTC monograph final
Authorization number:
50090-0004-1, 50090-0004-3, 50090-0004-5

PHARBEST ASPIRIN 325MG- aspirin tablet, delayed release

A-S Medication Solutions

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.

----------

Drug Facts

Active ingredient (in each tablet)

Aspirin 325mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpos e

Pain reliever

Us es

temporarily relieves minor aches and pains due to colds headache muscle pain menstrual

pain minor pains of arthritis toothache

or as receommended by your 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

facial swelling

asthma (wheezing)

shock

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID),

which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen,

or others)

take more or for a longer time than directed

have had stomach ulcers or bleeding problems

have 3 or more alcoholic drinks every day while using this product

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

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you are taking a diuretic

you have asthma

you have high blood pressure, heart disease, liver cirrhosis or kidney disease

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

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 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.

Directions

drink a full glass of water with each dose

adults and children 12

years and over

take 1 to 2 tablets every 4 hours while symptoms persist. Do not exceed 12

tablets in 24 hours unless diretced by a physician.

children under 12

years

consult a physician

Other information

avoid excess heat and moisture

store below 25 C (77 F)

Inactive ingredients

croscarmellose sodium, D&C yellow #10 Lake, FD&C red #6, hypromellose, methacrylic acid

copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, sodium lauryl sulfate,

starch, stearic acid, talc, titanium dioxide, triacetin.

Questions or comments?

Adverse drug event call: 1-866-562-2756

HOW SUPPLIED

Product: 50090-0004

NDC: 50090-0004-1 30 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 50090-0004-3 100 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 50090-0004-5 90 TABLET, DELAYED RELEASE in a BOTTLE

As pirin

PHARBEST ASPIRIN 325MG

aspirin tablet, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 0 9 0 -0 0 0 4(NDC:16 10 3-357)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

325 mg

A-S Medication Solutions

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

D&C RED NO . 6 (UNII: 48 1744AI4O)

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

METHACRYLIC ACID - METHYL METHACRYLATE CO PO LYMER ( 1:1) (UNII: 74G4R6 TH13)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

o ra nge

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

PH0 24

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 0 9 0 -0 0 0 4-1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/28 /20 14

2

NDC:50 0 9 0 -0 0 0 4-3

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/28 /20 14

3

NDC:50 0 9 0 -0 0 0 4-5

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/28 /20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt343

0 9 /20 /20 10

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -0 0 0 4) , REPACK(50 0 9 0 -0 0 0 4)

Revised: 4/2019

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