ASPIRIN LOW DOSE- aspirin tablet, chewable
Harmon Store 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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Core Values 44-218 Delisted

Active ingredient (in each chewable tablet)

Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommended 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
shock
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
have 3 or more alcoholic drinks every day while using this product
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
take more or for a longer time than directed

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
if you have ever had an allergic reaction to this product or any of its ingredients

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, liver cirrhosis, or kidney disease
you have asthma
you are taking a diuretic

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:
- vomit blood
- have bloody or black stools
- feel faint
- 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
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
chew or crush tablets completely before swallowing; do not swallow tablets whole
adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable tablets in 24 hours unless directed by a doctor
children under 12 years: do not use unless directed by a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, dextrates hydrated, FD&C yellow #6 aluminum lake, flavor, maltodextrin, sucralose

Questions or comments?

1-800-426-9391

Principal Display Panel

CORE VALUES™

Compare to active ingredient in Bayer®
Chewable Low Dose Aspirin†

Low Dose
Aspirin 81 mg
Chewable Tablets
Pain Reliever (NSAID)

Chew or crush tablets completely before swallowing.
Do not swallow tablets whole.

Actual Size orange flavor

36 chewable tablets

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

†This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Bayer® Chewable Low Dose Aspirin.

50844 ORG111821807

Distributed by: Liberty Procurement, Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www. facevalues.com

44-218A

ASPIRIN LOW DOSE
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63940-218
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	orange (light)	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	44;218
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63940-218-07	1 in 1 CARTON	09/12/1990	06/11/2023
1		36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	09/12/1990	06/11/2023

Labeler - Harmon Store Inc. (804085293)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(63940-218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(63940-218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(63940-218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(63940-218)

Revised: 1/2023

Document Id: c2ee194e-9687-4411-9f3d-ef981770aa54

Set id: 928a7c78-4b18-4e62-82ed-0d785227cb7e

Version: 8

Effective Time: 20230124

Harmon Store Inc.