ASPIRIN 81 MG- aspirin tablet, coated 
Reliable 1 Laboratories LLC

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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Aspirin 81mg EC

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains

Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief.

ask your doctor about other uses for enteric-coated 81 mg Aspirin

Warnings

Reye's syndrome: Children and teenagers who have or are recoving 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 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 steriod drug

- take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others)

- have 3 or more alcoholic drinks every day while using this product

- take more or for longer time than directed

Do not use: if you are allergic to aspirin or any other pain reliver/fever reducer

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

- an allergic reaction occurs. Seek medical help right away.

- you are experierance 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

- pain gets worse or lasts more than 10 days

- redness or swelling is present

- new symptoms occur

- ringing in the ears or a loss of hearing occurs.

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 becwause 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

- store at 25°C (77°F) excursions premitted between 15°-30°C (59°-86°F)

- Use by expiration date on package

Inactive ingredients

corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin.

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 are taking a diuretic

you have asthma

you have not been drinking fluids

you have lost a lot of fluid due to vomiting or diarrhea

Drug Facts

NDC 69168-066-02

Reliable-1

Adult Low Strength

Pain Reliever

Aspirin USP 81 mg (NSAID)

Enteric Coated

120 tablets

Compare to Active Ingredient in Aspirin Regimen BAYER®

Rev 01 Reliable-1 Aspirin 81 120 ct front panelRev 01 Reliable-1 Aspirin 81 120 ct back panelRev 01 Reliable-1 Aspirin 81 1000 ct front panelRev 01 Reliable-1 Aspirin 81 1000 ct back panel

ASPIRIN 81 MG 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-066
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POVIDONE (UNII: FZ989GH94E)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize5mm
FlavorImprint Code 17;S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69618-066-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
2NDC:69618-066-02120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/01/2020
Labeler - Reliable 1 Laboratories LLC (079718111)
Registrant - Reliable 1 Laboratories LLC (079718111)

Revised: 8/2023
Document Id: 0425633d-054a-bcef-e063-6294a90a1d32
Set id: b247fe39-7f65-e502-e053-2a95a90a08f1
Version: 6
Effective Time: 20230830
 
Reliable 1 Laboratories LLC