Non-aspirin
FDA Label NDC 52124-0010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genuine First Aid Llc for the product Non-aspirin (NDC 52124-0010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Acetaminophen 325 mg

Purpose

Analgesic/antipyretic

Uses


temporary relief of minor aches and pains associated with:

common cold;  headache; toothache; muscular aches;  backache; arthritis; menstrual cramps;  and reduction of fever

Warnings

Liver warning:   This product contains acetaminophen.

Severe liver damage may occur if:  adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours;  taken with other drugs containing acetaminophen;  adult has 3 or more alcoholic drinks every day while using this product

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription).  If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist;  for more than 10 days for pain unless directed by a doctor; for more than 3 days for fever unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if the user has liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Otc - Stop Use

Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur;  redness or swelling is present; a rare sensitivity reaction occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt
medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms.  Do not exceed recommended dosage

Inactive Ingredients

Cornstarch, polyethylene glycol, stearic acid, povidone

Dosage & Administration

Directions

Adults and Children                        Take 2 tablets every 4 to 6 hours as

12 years of age                               needed.  Do not take more than 12 tablets

or older                                          in 24 hours.



Children 6-11 years                           Take 1 tablet every 4 to 6 hours as

of age                                               needed.  Do not take more than 5

                                                        tablets in 24 hours.



Children under 6                                Do not use this regular strength product.

years of age                                      This will provide more than the

                                                         recommended dose (overdose) and could

                                                         cause serious health problems.

Storage And Handling

Store at 59-86 degree F (15-30 degree C)


General Precautions

tamper evident sealed packets; do not use any open or torn packets

Description

Distributed by GENUINE FIRST AID
600 Cleveland Str Suite 400, Clearwater, FL 33755

Package Label.Principal Display Panel

Non Aspirin (Non Aspirin)

Non Aspirin (Non Aspirin)

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