Acetaminophen, aspirin and salicylamide

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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
Acetaminophen, aspirin and salicylamide is an analgesic that is FDA approved for the treatment of temporarily relieves pain dut to headache, muscular aches, cold, flu, fever.   Common adverse reactions include hypersensitivity.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Temporarily relieves pain dut to: headache, muscular aches, cold, flu.
- Temporarily reduces fever.
- Adults: Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours
- Children under 12 years, ask a doctor

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen, aspirin and salicylamide in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Acetaminophen, aspirin and salicylamide in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Acetaminophen, aspirin and salicylamide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen, aspirin and salicylamide in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Acetaminophen, aspirin and salicylamide in pediatric patients.

# Contraindications
There is limited information regarding Acetaminophen, aspirin and salicylamide Contraindications in the drug label.

# Warnings
- Liver Warning: This product contains acetaminophen. Severe liver damage
- May occur if you take:
- More than 8 tablets in 24 hours
- With other drugs containing acetaminophen (prescription or nonprescription).  Ask a doctor or pharmacist before using with other drugs if you are not sure.
- 3 or more alcoholic drinks every day while using this product
- Do not use:
- With any other product containing acetaminophen this will provide more
than the recommended dose (overdose) of acetaminophen and could
- Cause serious health concerns.
- For more than 10 days for pain unless directed by a doctor.
- For more than 3 days for fever unless directed by a doctor.
- When using this product do not exceed recommended dose.
- Stop use and ask a doctor if:
- Symptoms do not improve.
- Pain or fever persists or gets worse.
- New symptoms occur.
- Redness or swelling is present.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Acetaminophen, aspirin and salicylamide Clinical Trials Experience in the drug label.

## Postmarketing Experience
There is limited information regarding Acetaminophen, aspirin and salicylamide Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Acetaminophen, aspirin and salicylamide Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Acetaminophen, aspirin and salicylamide in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Acetaminophen, aspirin and salicylamide in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Acetaminophen, aspirin and salicylamide during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in geriatric settings.

### Gender
There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Acetaminophen, aspirin and salicylamide in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Acetaminophen, aspirin and salicylamide in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Acetaminophen, aspirin and salicylamide Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Acetaminophen, aspirin and salicylamide and IV administrations.

# Overdosage
There is limited information regarding Acetaminophen, aspirin and salicylamide overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology
There is limited information regarding Acetaminophen, aspirin and salicylamide Pharmacology in the drug label.

## Mechanism of Action
There is limited information regarding Acetaminophen, aspirin and salicylamide Mechanism of Action in the drug label.

## Structure
There is limited information regarding Acetaminophen, aspirin and salicylamide Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Acetaminophen, aspirin and salicylamide Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Acetaminophen, aspirin and salicylamide Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Acetaminophen, aspirin and salicylamide Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Acetaminophen, aspirin and salicylamide Clinical Studies in the drug label.

# How Supplied
There is limited information regarding Acetaminophen, aspirin and salicylamide How Supplied in the drug label.

## Storage
There is limited information regarding Acetaminophen, aspirin and salicylamide Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Acetaminophen, aspirin and salicylamide Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Acetaminophen, aspirin and salicylamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- ZEE PAIN AID

# Look-Alike Drug Names
There is limited information regarding Acetaminophen, aspirin and salicylamide Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price