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 44-397-Discontinued

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

fred's pharmacy 44-397

ASPIRIN  CHEWABLE LOW DOSE
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-397
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorCHERRYImprint Code 44;397
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-397-071 in 1 CARTON09/04/200103/09/2022
136 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/04/200103/09/2022
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(55315-397)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(55315-397)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55315-397)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55315-397)

Revised: 4/2019
Document Id: 27647c29-4624-4875-bbeb-77d1bb48ae17
Set id: e79c7ab4-ba8f-4ce3-90d8-82f6733b93d5
Version: 3
Effective Time: 20190416
 
FRED'S, INC.