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Aspirin Low Dose Safety Coated

Medically reviewed on August 1, 2017

Dosage form: tablet, coated
Ingredients: ASPIRIN 81mg
Labeler: Proficient Rx LP
NDC Code: 63187-882

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.

DRUG FACTS

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. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for safety coated 81 mg aspirin

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
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

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
pain gets worse or lasts more than 10 days
redness or swelling is present
ringing in the ears or loss of hearing occurs

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 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

Other information
store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

anhydrous lactose**, black iron oxide**, brown iron oxide**, croscarmellose sodium**, D&C yellow #10, FD&C yellow #6**, hypromellose**, methacrylic acid copolymer, microcrystalline cellulose, mineral oil**, polysorbate 80**,  potassium hydroxide**, pregelatinized starch**, propylene glycol**, purified water**, shellac**, silicon dioxide, simethicone**, sodium bicarbonate**, sodium hydroxide**, sodium lauryl sulfate**, stearic acid**, talc, titanium dioxide, triethyl citrate, yellow iron oxide**

**contains one or more of these ingredients 

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

‡Aspirin Regimen

Low Dose Safety Coated

Aspirin 81 mg

Pain Reliever (NSAID)

†Compare to active ingredient in Bayer® Low Dose Aspirin

Enteric Coated Tablets

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

‡Aspirin is not appropriate for everyone, so be sure you talk to your doctor before you begin an aspirin regimen.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Ditributed by: Geiss, Destin & Dunn, Inc.

Peachtree City, GA  30269

Relabeled by: Proficient Rx LP

Thousand Oaks, CA 91320

ASPIRIN  LOW DOSE SAFETY COATED
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-882(NDC:50804-227)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 
DIMETHICONE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TRIETHYL CITRATE 
ANHYDROUS LACTOSE 
FERROSOFERRIC OXIDE 
BROWN IRON OXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSE, UNSPECIFIED 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
MICROCRYSTALLINE CELLULOSE 
MINERAL OIL 
POTASSIUM HYDROXIDE 
STARCH, CORN 
PROPYLENE GLYCOL 
WATER 
SHELLAC 
SILICON DIOXIDE 
SODIUM BICARBONATE 
STEARIC ACID 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeE;T81;1
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-882-3030 TABLET, COATED in 1 BOTTLE, PLASTIC
2NDC:63187-882-3636 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:63187-882-6060 TABLET, COATED in 1 BOTTLE, PLASTIC
4NDC:63187-882-9090 TABLET, COATED in 1 BOTTLE, PLASTIC
5NDC:63187-882-72120 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/15/2013
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-882), RELABEL(63187-882)

 
Proficient Rx LP

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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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