ASPIRIN LOW DOSE- aspirin tablet, chewable
GREENBRIER INTERNATIONAL, INC.

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Assured 44-218A-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

take a blood thinning (anticoagulant) or steroid drug
are age 60 or older
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
have had stomach ulcers or bleeding problems

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

Assured™

COMPARE TO ACTIVE INGREDIENT OF
BAYER® CHEWABLE LOW DOSE ASPIRIN†

Chewable Low Dose
Aspirin

81 mg, Chewable Tablets
Pain reliever (NSAID)

Chew or crush tablets completely
before swallowing.

Orange Flavored

Actual Size

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 REV1118A21807

DISTRIBUTED BY:
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY,
CHESAPEAKE, VA 23320

Assured 44-218A

ASPIRIN LOW DOSE
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-0218
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	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:33992-0218-7	1 in 1 CARTON	09/12/1990	02/12/2023
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 Drug	M013	09/12/1990	02/12/2023

Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(33992-0218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(33992-0218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(33992-0218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(33992-0218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(33992-0218)

Revised: 10/2023

Document Id: 62278f61-3c99-4b5c-98a6-f53f01f3892f

Set id: c301bb74-2e38-40f7-ab64-8239e9cf5641

Version: 9

Effective Time: 20231021

GREENBRIER INTERNATIONAL, INC.