ASPIRIN CHEWABLE LOW DOSE- aspirin tablet, chewable

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by FRED'S, INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• facial swelling
• asthma (wheezing)
• hives
• shock

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 other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• 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 

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

• you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
• an allergic reaction occurs. Seek medical help right away.
• new symptoms occur
• ringing in the ears or loss of hearing occurs
• pain gets worse or lasts more than 10 days
• redness or swelling is present

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

cherry flavor, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, sodium saccharin

Questions or comments?

1-800-426-9391

Principal display panel

Fred's Pharmacy

NDC: 55315-397-07

ACTUAL SIZE

CHEWABLE LOW DOSE

ASPIRIN
Pain Reliever (NSAID)
81 mg each

36 TABLETS

ASPIRIN REGIMEN

CHERRY FLAVORED

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

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)

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

50844   ORG061339707

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

fred's pharmacy 44-397

INGREDIENTS AND APPEARANCE

ASPIRIN  CHEWABLE LOW DOSE
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-397
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
DEXTRATES (UNII: G263MI44RU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C RED NO. 30 (UNII: 2S42T2808B)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	8mm
Flavor	CHERRY	Imprint Code	44;397
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-397-07	1 in 1 CARTON	09/04/2001	03/09/2022
1		36 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	09/04/2001	03/09/2022

Labeler - FRED'S, INC. (005866116)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(55315-397)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(55315-397)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(55315-397)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(55315-397)