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ASPIRIN by Proficient Rx LP

Medically reviewed on Mar 27, 2018

Dosage form: tablet, extended release
Ingredients: ASPIRIN 81mg
Labeler: Proficient Rx LP
NDC Code: 63187-297

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
temporarily relieves minor aches and pains
for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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
asthma (wheezing)
shock

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

have  had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
take more or for a longer time than directed
are age 60 or older
have 3 or more alcoholic drinks every day while using this product

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
you have not been drinking fluids
you have lost a lot of fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are
taking a prescription drug for diabetes, gout, or arthritis
taking any other drug
under a doctor's care for any serious condition

Stop use and ask a doctor if
you experience any of the following signs of stomach bleedin


                feel faint
                vomit blood
                have  bloody or black stools

have stomach pain that does not get better
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear
ringing in the ears or a 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: consult a doctor

Other information
Do not use if imprinted safety seal under cap is broken or missing.
store at 250C (770 F) excursions permitted between 150-300C (590-860 F)

Inactive ingredients:

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, D and C Yellow #10 Aluminum Lake, Iron Oxide Ochre, Methacrylic Acid Copolymer, Microcrystalline Cellulose, Polysorbate 80, Simethicone, Sodium Hydroxide, Sodium Lauryl Sulfate, Talc, Titanium Dioxide, Triethyl Citrate.

Questions?

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

PlusPHARMA

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
ASPIRIN
81 mg
NSAID
PAIN RELIEVER
LOW DOSE ASPIRIN REGIMEN

Safety Coated-Enteric Coated
Delayed Release Aspirin Tablets
Small, Easy-to-Swallow Tablets

*Compare to the active ingredient in Bayer Low Dose
*This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Bayer Low Dose.
120 TABLETS

81 mg each
ASPIRIN 
aspirin tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-297(NDC:51645-717)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColoryellowScoreno score
ShapeROUND (YELLOW) Size7mm
FlavorImprint CodeRAISED;HEART
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-297-72120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/10/2013
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022REPACK(63187-297), RELABEL(63187-297)

 
Proficient Rx LP

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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