Amazon Basics Acetaminophen Tablet
FDA Label NDC 72288-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amazon.com Services Llc for the product Amazon Basics Acetaminophen (NDC 72288-008). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
    • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
  • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • If a skin reaction occurs, stop use and seek medical help right away.

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts 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 health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 gelcaps every 6 hours while symptoms last
    • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children under 12 years
    ask a doctor

Other Information

  • store between 20° to 25°C (68° to 77°F). Avoid high humidity
  • do not use if carton is open. Do not use if printed foil seal under cap is torn or missing

Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions Or Comments?

call 1-855-274-4122
 

DISTRIBUTED BY:

AMAZON.COM SERVICES LLC, SEATTLE, WA 98109
1-877-485-0385

©2025 AMAZON.COM INC. OR ITS AFFILIATES.
ALL RIGHTS RESERVED.

WWW.AMAZON.COM/AMAZONBASICS

Package Label-Principal Display Panel 500 Mg (100 Gelcaps Container Label)

amazon basics

NDC 72288-008-10

Extra Strength
Acetaminophen
Rapid Release Gelcaps, 500 mg
Pain Reliever / Fever Reducer

 ___________________________

For Adults

DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN

100 GELCAPS    500 mg EACH

  

Package Label-principal Display Panel 500 mg (100 Gelcaps Container Label) (Acetaminophen Fig1)

Package Label-principal Display Panel 500 mg (100 Gelcaps Container Label) (Acetaminophen Fig1)

Package Label-Principal Display Panel 500 Mg (100 Gelcaps Container Carton)

amazon basics

Compare to
Tylenol®
Extra Strength
Rapid Release Gels
active ingredient**

NDC 72288-008-10

Extra Strength
Acetaminophen
Rapid Release Gelcaps, 500 mg
Pain Reliever / Fever Reducer

______________________________

For Adults |  Contains No Aspirin

DO NOT USE WITH OTHER
MEDICINES CONTAINING
ACETAMINOPHEN

actual size

100 GELCAPS | 500 mg EACH

Package Label-principal Display Panel 500 mg (24 Gelcaps Container Carton) (Acetaminophen Fig2)

Package Label-principal Display Panel 500 mg (24 Gelcaps Container Carton) (Acetaminophen Fig2)

* Please review the disclaimer below.