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ASPIRIN LOW DOSE by FRED'S, INC.

Medically reviewed on May 22, 2017

Dosage form: tablet, coated
Ingredients: ASPIRIN 81mg
Labeler: FRED'S, INC.
NDC Code: 55315-645

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.

Freds Pharmacy 44-645

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:

  • 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
  • are age 60 or older
  • 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.

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

colloidal silicon dioxide, corn starch, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

 1-800-426-9391

Principal Display Panel

fred's
Pharmacy

NDC 55315-645-32

LOW DOSE

ASPIRIN

PAIN RELIEVER (NSAID)

120 ENTERIC
COATED TABLETS

81 mg each

SAFETY COATED
ASPIRIN REGIMEN

Compare to the active ingredient in:
St. Joseph® Low Dose
Safety Coated 81 mg Aspirin†

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

†This product is not manufactured or distributed by St. Josephs Healthcare Products, LLC, owner of the registered trademark St. Joseph® Low Dose Safety Coated 81 mg Aspirin.

50844 ORG121364532

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

100% satisfaction guaranteed


Freds 44-645


ASPIRIN  LOW DOSE
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-645
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
METHACRYLIC ACID 
MICROCRYSTALLINE CELLULOSE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeL
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-645-321 BOTTLE in 1 CARTON
1120 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/25/2014
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-645)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-645)

 
FRED'S, INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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