Amazon Basic Care Acetaminophen Tablet, Extended Release
FDA Label NDC 72288-698

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 72288-698). 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, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label-principal Display Panel - 650 Mg (24 Tablets Bottle)

→ Package Label-principal Display Panel - 650 Mg (24 Tablets Container Carton)

Drug Facts

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

more than 6 tablets in 24 hours, which is the maximum daily amount
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 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 tablets in 24 hours do not use for more than 10 days unless directed by a doctor.
children under 12 years	do not use

Other Information

store at 20^o to 25^oC (68^o to 77^oF). Avoid excessive heat 40^oC (104^oF).
do not use if carton is opened or foil inner seal is broken
Meets USP dissolution test 3

Inactive Ingredients

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

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