Aspirin (delayed release tablet)

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.

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.

• 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.

• 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.

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

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

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

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

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

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

• 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.

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

• Oral.

• Intravenous.

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

• ASPIRIN DELAYED RELEASE®^[3]

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

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