Acetaminophen Tablet
FDA Label NDC 69822-692

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Service, Inc. for the product Acetaminophen (NDC 69822-692). 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings • liver warning, do not use, ask a doctor before use if the user has, ask a doctor or pharmacist before use if the user is, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

for the temporary relief of minor aches and pains due to:

Headache

Muscular aches

Backache

Toothache

Premenstrual and menstrual cramps

Temporally reduces 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) 
  • you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If The User Has

liver disease

Ask A Doctor Or Pharmacist Before Use If The User Is

taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

Pain gets worse or lasts more than 10 days in adults.

Pain gets worse or lasts more than 5 days in children under under 12 years

Fever gets worse or last more than 3 days

new symptoms occur

Redness or swelling is present. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a doctor before use.

Keep Out Of The Reach Of Children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or syptoms.

  • Do not take more tahn directed (see overdose warning)

Directions

Directions 

 Adults and Children

12 years and older

Take 2 tablets every 4 to 6 hours while symptoms last

Do not take more than 12 tablets in 24 hours

Children

6 to 11 years

Take 1 tablet every 4 to 6 hours while symptoms last

Do not take more than 5 tablets in 24 hours

Children under

6 years     

Do not use regular Strength products in children uder 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage. 

Other Information

store at room temperature 20°-25°C (68-77°F)

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

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