Amazon Basic Care Acetaminophen Tablet
FDA Label NDC 72288-692

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amazon.com Services Llc for the product Amazon Basic Care Acetaminophen (NDC 72288-692). 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, purpose, uses, warnings, do not use, otc - ask doctor, 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.

Label Section Quick Index

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:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • 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

Otc - Ask Doctor

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.

Otc - Pregnancy Or Breast Feeding

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 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets 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)
  • do not use if carton is open or if printed foil seal under cap is torn or missing.

Inactive Ingredients

povidone, pregelatinized starch (maize), stearic acid.

Questions Or Comments?

call 1-855-274-4122

DISTRIBUTED BY:
AMAZON.COM SERVICES LLC
410 TERRY AVENUE N.
SEATTLE, WA 98109

Made in India

Package Label-Principal Display Panel 500 Mg (100 Caplets Bottle)

amazon
basic+care

Extra Strength
NDC 72288-692-10

See New Warnings Information
& Directions

Acetaminophen
Caplets 500 mg
Pain Reliever/Fever Reducer
For Adults
Contains No Aspirin

100 CAPLETS
500 mg EACH

Package Label-principal Display Panel 500 mg (100 Caplets Bottle) (Acetaminophen Fig1)

Package Label-principal Display Panel 500 mg (100 Caplets Bottle) (Acetaminophen Fig1)

Package Label-Principal Display Panel 500 Mg (100 Caplets Bottle Carton)

amazon
basic+care

Extra Strength
NDC 72288-692-10
Compare to
Extra Strength
Tylenol® Caplets
active ingredient*

See New Warnings Information & Directions

Acetaminophen
Caplets 500 mg
Pain Reliever/Fever Reducer
For Adults
Contains No Aspirin

100 CAPLETS
500 mg EACH


Package Label-principal Display Panel 500 mg (100 Caplets Bottle) (Acetaminophen Fig2)

Package Label-principal Display Panel 500 mg (100 Caplets Bottle) (Acetaminophen Fig2)

* Please review the disclaimer below.