ASPIRIN- aspirin tablet, film coated
New Genesis/Monticello Drug LLC

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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Norwich 44-157-Delisted

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves:

minor pain of arthritis
headache
muscle pain
menstrual 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 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:

facial swelling
shock
hives
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
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 are allergic to aspirin or any other pain reliever/fever reducer
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

you are taking a diuretic
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 have asthma

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
ringing in the ears or a loss of hearing occurs
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

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 (1-800-222-1222) right away.

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
children under 12 years: do not use unless directed by a doctor

Other information

use by expiration date on package
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

Principal display panel

Family trusted for over 100 years

Norwich®

ASPIRIN
Pain Reliever/Fever Reducer
(NSAID) 325 mg per tablet

Talk to your doctor or other healthcare
provider before using this product for your heart.

REGULAR STREGTH

100 COATED
TABLETS

Actual Size

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

50844 REV0318B15712

Distributed by:
New Genesis/Monticello Drug LLC
Jacksonville, FL 32207
www.newgenesismonticellodrug.com (904) 647-7825

Norwich 44-157

ASPIRIN
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11868-157
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, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ASPIRIN;44;157
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11868-157-12	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/1996	01/27/2021
2	NDC:11868-157-17	300 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/1996	01/27/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	02/10/1996	01/27/2021

Labeler - New Genesis/Monticello Drug LLC (079396165)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	MANUFACTURE(11868-157)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(11868-157)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(11868-157)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(11868-157)

Revised: 1/2021

Document Id: 3526a2e9-6e4d-4207-b4d9-888ad293a1e5

Set id: 58278504-47c3-4fde-9b63-d12e508e5c3c

Version: 6

Effective Time: 20210125

New Genesis/Monticello Drug LLC