Aspirin (delayed release tablet)

Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief:  Ammu Susheela, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

## Overview

Aspirin (delayed release tablet) is an analgesic that is FDA approved for the treatment of minor aches and pains. Common adverse reactions include dyspepsia, hypoprothrombinemia, thrombocytopenia, hypersensitivity, cholestatic hepatitis, and tinnitus.

## Adult Indications and Dosage

### FDA-Labeled Indications and Dosage (Adult)

##### Indications

* 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.

##### Dosage

* 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.

### Off-Label Use and Dosage (Adult)

#### Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Aspirin (delayed release tablet) in adult patients.

#### Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Aspirin (delayed release tablet) in adult patients.

## Pediatric Indications and Dosage

### FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Aspirin (delayed release tablet) in pediatric patients.

### Off-Label Use and Dosage (Pediatric)

#### Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Aspirin (delayed release tablet) in pediatric patients.

#### Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Aspirin (delayed release tablet) in pediatric patients.

## Contraindications

There is limited information regarding Aspirin (delayed release tablet) Contraindications in the drug label.

## 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) 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.

## Adverse Reactions

### Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Aspirin (delayed release tablet) in the drug label.

### Postmarketing Experience

Dyspepsia, hypoprothrombinemia, thrombocytopenia, hypersensitivity, cholestatic hepatitis, tinnitus.

## Drug Interactions

There is limited information regarding Aspirin (delayed release tablet) Drug Interactions in the drug label.

## Use in Specific Populations

#### Pregnancy

Pregnancy Category (FDA):

* 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.

Pregnancy Category (AUS):

* Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Aspirin (delayed release tablet) in women who are pregnant.

#### Labor and Delivery

There is no FDA guidance on use of Aspirin (delayed release tablet) during labor and delivery.

#### Nursing Mothers

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to nursing mothers.

#### Pediatric Use

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to pediatric patients.

#### Geriatic Use

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to geriatric patients.

#### Gender

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to specific gender populations.

#### Race

There is no FDA guidance on the use of Aspirin (delayed release tablet) with respect to specific racial populations.

#### Renal Impairment

There is no FDA guidance on the use of Aspirin (delayed release tablet) in patients with renal impairment.

#### Hepatic Impairment

There is no FDA guidance on the use of Aspirin (delayed release tablet) in patients with hepatic impairment.

#### Females of Reproductive Potential and Males

There is no FDA guidance on the use of Aspirin (delayed release tablet) in women of reproductive potentials and males.

#### Immunocompromised Patients

There is no FDA guidance one the use of Aspirin (delayed release tablet) in patients who are immunocompromised.

## Administration and Monitoring

#### Administration

* Oral.

* Intravenous.

#### Monitoring

There is limited information regarding Monitoring of Aspirin (delayed release tablet) in the drug label.

## IV Compatibility

There is limited information regarding IV Compatibility of Aspirin (delayed release tablet) in the drug label.

## Overdosage

There is limited information regarding Chronic Overdose of Aspirin (delayed release tablet) in the drug label.

## Pharmacology

Template:Px

Aspirin (delayed release tablet)

Systematic (IUPAC) name
2-(acetoxy)benzoic acid
Identifiers
CAS number | 50-78-2
ATC code | A01AD05 B01AC06 (WHO), N02BA01 (WHO)
PubChem | 2244
DrugBank | DB00945
Chemical data
Formula | Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass | 180.157 g/mol
SMILES | eMolecules & PubChem
Synonyms | 2-acetoxybenzoic acid
acetylsalicylate
acetylsalicylic acid
O-acetylsalicylic acid
Physical data
Density | 1.40 g/cm³
Melt. point | 136 °C (277 °F)
Boiling point | 140 °C (284 °F) (decomposes)
Solubility in water | 3 mg/mL (20 °C)
Pharmacokinetic data
Bioavailability | 80–100%[1]
Protein binding | 80–90%[2]
Metabolism | Hepatic, (CYP2C19 and possibly CYP3A), some is also hydrolysed to salicylate in the gut wall.[2]
Half life | Dose-dependent; 2–3 hours for low doses, 15–30 hours for large doses.[2]
Excretion | Urine (80–100%), sweat, saliva, feces[1]
Therapeutic considerations
Pregnancy cat. |

C(AU) C(US)

Legal status |

Pharmacy Only (S2)(AU) GSL(UK) OTC(US)

Routes | Most commonly oral, also rectal, lysine acetylsalicylate may be given intravenously or intramuscularly

### Mechanism of Action

There is limited information regarding Aspirin (delayed release tablet) Mechanism of Action in the drug label.

### Structure

There is limited information regarding Aspirin (delayed release tablet) Structure in the drug label.

### Pharmacodynamics

There is limited information regarding Pharmacodynamics of Aspirin (delayed release tablet) in the drug label.

### Pharmacokinetics

There is limited information regarding Pharmacokinetics of Aspirin (delayed release tablet) in the drug label.

### Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Aspirin (delayed release tablet) in the drug label.

## Clinical Studies

There is limited information regarding Clinical Studies of Aspirin (delayed release tablet) in the drug label.

## How Supplied

There is limited information regarding Aspirin (delayed release tablet) How Supplied in the drug label.

### Storage

There is limited information regarding Aspirin (delayed release tablet) Storage in the drug label.

## Images

### Drug Images

Drug Name: Aggrenox
Ingredient(s): aspirin[aspirin], dipyridamole[dipyridamole]
Imprint: 01A;
Dosage: 25 mg
Color(s):
Shape: Capsule
Size (mm): 24
Score: 1
NDC:05970001

Drug Label Author: Boehringer Ingelheim Pharmaceuticals, Inc.

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Ascomp with Codeine
Ingredient(s): Butalbital[Butalbital], Aspirin[Aspirin], Caffeine[Caffeine], Codeine Phosphate[Codeine]
Imprint: B074
Dosage: 325 mg
Color(s):
Shape: Capsule
Size (mm): 22
Score: 1
NDC:519910074

Drug Label Author: Breckenridge Pharmaceutical, Inc.

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspir Low
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: N
Dosage: 81 mg
Color(s): Yellow
Shape: Round
Size (mm): 7
Score: 1
NDC:09047704

Drug Label Author: Major Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspirin EC
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: N
Dosage: 81 mg
Color(s): Yellow
Shape: Round
Size (mm): 7
Score: 1
NDC:01821061

Drug Label Author: Goldline Laboratories, Inc.

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: AP;121
Dosage: 81 mg
Color(s): Yellow
Shape: Round
Size (mm): 8
Score: 1
NDC:05363086

Drug Label Author: Rugby Laboratories Inc.

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: AZ013
Dosage: 81 mg
Color(s): Orange
Shape: Round
Size (mm): 8
Score: 1
NDC:06030024

Drug Label Author: Qualitest Pharmaceutical, Inc.

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: L467
Dosage: 81 mg
Color(s): Orange
Shape: Round
Size (mm): 8
Score: 1
NDC:09044040

Drug Label Author: Major Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: TCL;334;UPPER;LOWER;PLAIN
Dosage: 81 mg
Color(s): Orange
Shape: Round
Size (mm): 8
Score: 1
NDC:09046288

Drug Label Author: Major Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: ASPIRIN;44157
Dosage: 325 mg
Color(s): White
Shape: Round
Size (mm): 11
Score: 1
NDC:508440157

Drug Label Author: L.N.K. International, Inc.

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: ASPIRIN;44249
Dosage: 325 mg
Color(s): White
Shape: Round
Size (mm): 11
Score: 1
NDC:508440249

Drug Label Author: L.N.K. International, Inc.

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Butalbital, Aspirin, Caffeine and Codeine Phosphate
Ingredient(s): CODEINE PHOSPHATE[CODEINE ANHYDROUS], BUTALBITAL[BUTALBITAL], CAFFEINE[CAFFEINE], ASPIRIN[ASPIRIN]
Imprint: WATSON;3546
Dosage: 325 mg
Color(s):
Shape: Capsule
Size (mm): 22
Score: 1
NDC:05913546

Drug Label Author: Watson Laboratories, Inc.

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Butalbital, Aspirin and Caffeine
Ingredient(s): BUTALBITAL[BUTALBITAL], ASPIRIN[ASPIRIN], CAFFEINE[CAFFEINE]
Imprint: Westward;785
Dosage: 325 mg
Color(s): White
Shape: Round
Size (mm): 11
Score: 1
NDC:01431785

Drug Label Author: West-ward Pharmaceutical Corp

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Butalbital, Aspirin, and Caffeine
Ingredient(s): BUTALBITAL[BUTALBITAL], ASPIRIN[ASPIRIN], CAFFEINE[CAFFEINE]
Imprint: WATSON;3219
Dosage: 325 mg
Color(s):
Shape: Capsule
Size (mm): 22
Score: 1
NDC:05913219

Drug Label Author: Watson Laboratories, Inc.

This pill image is provided by the National Library of Medicine's PillBox.
File:Butalbital Aspirin and Caffeine Tablets NDC 06032548.jpg

Drug Name: Butalbital, Aspirin and Caffeine Tablets
Ingredient(s): ASPIRIN[ASPIRIN], BUTALBITAL[BUTALBITAL], CAFFEINE[CAFFEINE]
Imprint: West;ward;785
Dosage: 325 mg
Color(s): White
Shape: Round
Size (mm): 7
Score: 1
NDC:06032548

Drug Label Author: Qualitest

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Enteric Coated Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: T
Dosage: 325 mg
Color(s): Orange
Shape: Round
Size (mm): 11
Score: 1
NDC:05363313

Drug Label Author: Rugby Laboratories, Inc

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Enteric Coated Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: T;A
Dosage: 325 mg
Color(s): Orange
Shape: Round
Size (mm): 11
Score: 1
NDC:06030169

Drug Label Author: Qualitest Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Low Strength Chewable Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: AZ;013
Dosage: 81 mg
Color(s): Orange
Shape: Round
Size (mm): 7
Score: 1
NDC:578960911

Drug Label Author: Geri-Care Pharmaceutical Corp

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Micro-Coated Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: TCL;011
Dosage: 325 mg
Color(s): White
Shape: Round
Size (mm): 10
Score: 1
NDC:05363305

Drug Label Author: Rugby Laboratories, Inc

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Regular Strength Aspirin EC
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: T
Dosage: 325 mg
Color(s): Orange
Shape: Round
Size (mm): 11
Score: 1
NDC:09042011

Drug Label Author: Major Pharmaceuticals Inc

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Regular Strength Aspirin EC
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: T
Dosage: 325 mg
Color(s): Orange
Shape: Round
Size (mm): 11
Score: 1
NDC:09042013

Drug Label Author: Major Pharmaceuticals Inc

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Regular Strength Aspirin EC
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: T
Dosage: 325 mg
Color(s): Orange
Shape: Round
Size (mm): 11
Score: 1
NDC:675440468

Drug Label Author: Aphena Pharma Solutions - Tennessee, LLC

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Regular Strength Enteric coated aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: 44;227
Dosage: 325 mg
Color(s): Orange
Shape: Round
Size (mm): 9
Score: 1
NDC:578960921

Drug Label Author: Geri-Care Pharmaceutical Corp

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspirin
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: 44;183
Dosage: 325 mg
Color(s): White
Shape: Round
Size (mm): 11
Score: 1
NDC:09042015

Drug Label Author: Major Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.

Drug Name: Aspirin regular strength
Ingredient(s): ASPIRIN[ASPIRIN]
Imprint: Aspirin;A1
Dosage: 325 mg
Color(s): White
Shape: Round
Size (mm): 11
Score: 1
NDC:09042009

Drug Label Author: Major Pharmaceuticals

This pill image is provided by the National Library of Medicine's PillBox.

### Package and Label Display Panel

This image is provided by the National Library of Medicine. This image is provided by the National Library of Medicine.

## Patient Counseling Information

There is limited information regarding Patient Counseling Information of Aspirin (delayed release tablet) in the drug label.

## Precautions with Alcohol

* Alcohol-Aspirin (delayed release tablet) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

## Brand Names

* ASPIRIN DELAYED RELEASE®[3]

## Look-Alike Drug Names

There is limited information regarding Aspirin (delayed release tablet) Look-Alike Drug Names in the drug label.

## Drug Shortage Status

## Price

## References

The contents of this FDA label are provided by the National Library of Medicine.

1. ↑ 1.0 1.1 "Zorprin, Bayer Buffered Aspirin (aspirin) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 3 April 2014.
2. ↑ 2.0 2.1 2.2 Brayfield, A, ed. (14 January 2014). "Aspirin". Martindale: The Complete Drug Reference. Pharmaceutical Press. Retrieved 3 April 2014.
3. ↑ "ASPIRIN DELAYED RELEASE- aspirin tablet, delayed release".

Cardiology