Acetaminophen
FDA Label NDC 77800-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Healthright Products, Llc for the product Acetaminophen (NDC 77800-100). 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 other, active ingredient (in each caplet), purpose, uses, do not use, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Important: Read all product information before using. Keep this box for important information.

Drug Facts

Active Ingredient (In Each Caplet)

Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to

  • headache
  • tooth pain
  • backache
  • PMS and menstrual cramps
  • temporarily reduces fever
  • minor arthritis
  • the common cold
  • muscular pain 

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

Stop Use And Ask A Doctor If

  • You are suffering from any liver disease
  • you are taking the blood thinning drug warfarin
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse

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.

Overdosage

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. 

Dosage

Adults and children over 12 years of age, Take 2 caplets every 6 hours while symptoms last, do not take more than 6 caplets in 24 hours, unless directed by a doctor. 

Children under 12, ask a doctor. 

Storage

  • Store in a cool and dry place
  • Store between 22-25˚C (67-77˚F)

Inactive Ingredients

Micro crystalline Cellulose, Corn Starch, Sodium Starch Glycolate Type A, Sodium Lauryl sulfate, Sodium Methyl Paraben, Magnesium Stearate, Talc, Croscarmellose Sodium and polyvinyl pyrrolidone K-30

Information

Tamper Evident: Do not use if safety seal under cap is broken or missing

Swallow whole, do not crush, chew, split or dissolve

Principal Display Panel - 200 Ct

Acetaminophen Caplet, 500 mg

Pain Reliever - Fever Reducer

* Please review the disclaimer below.