ASPIRIN CHEWABLE, LOW DOSE- aspirin tablet, chewable
FRED'S, 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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Freds Pharmacy 44-218A

Active ingredient (in each 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
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 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

fred's
Pharmacy

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

NDC 55315-218-07

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

CHEWABLE LOW DOSE
ASPIRIN
Pain Reliever (NSAID)

ASPIRIN REGIMEN

81 mg
each

ORANGE
FLAVORED

36 TABLETS

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

†This product is not manufactured or distributed by
Bayer HealthCare LLC, owner of the registered
trademark Bayer® Chewable Low Dose Aspirin.
50844 ORG041821807

DISTRIBUTED BY: fred's Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction
guaranteed
Questions or comments: 1-855-331-FRED (3733)

Freds Pharmacy 44-218A

ASPIRIN CHEWABLE, LOW DOSE
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55315-218
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)

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:55315-218-07	1 in 1 CARTON	09/12/1990	04/08/2022
1		36 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 NOT FINAL	part343	09/12/1990	04/08/2022

Labeler - FRED'S, INC. (005866116)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(55315-218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(55315-218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(55315-218)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(55315-218)

Revised: 6/2020

Document Id: 18fc4141-c01f-48f7-8fb1-56d39f1d7efb

Set id: 0e7aabbe-b0ee-4d07-808e-c874effe67f4

Version: 5

Effective Time: 20200611

FRED'S, INC.