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Amazon basic care acetaminophen - Medication Information

Product NDC Code 72288-698
Drug Name

Amazon basic care acetaminophen

Type Brand
Active Ingredients
Acetaminophen 650 mg/1
Route ORAL
Dosage Form TABLET, EXTENDED RELEASE
RxCUI drug identifier 1148399
Application Number ANDA207229
Labeler Name Amazon.com Services LLC
Packages
Package NDC Code Description
72288-698-10 1 bottle in 1 carton (72288-698-10) / 100 tablet, extended release in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Drug Facts Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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
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 hoursdo not use for more than 10 days unless directed by a doctor.
children under 12 years do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin Questions or comments? call 1-855-274-4122 DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N., SEATTLE, WA 98109 ©2024 AMAZON.COM, INC. OR ITS AFFILIATES. ALL RIGHTS RESERVED. Made in India

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purpose Pain reliever/fever reducer

Spl product data elements

Usually a list of ingredients in a drug product.
AMAZON BASIC CARE ACETAMINOPHEN Acetaminophen ACETAMINOPHEN ACETAMINOPHEN SILICON DIOXIDE HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED STARCH, CORN SODIUM STARCH GLYCOLATE TYPE B POTATO TITANIUM DIOXIDE TRIACETIN White to Off-White Caplet I;06

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Bottle) amazon basic+care 8 Hour NDC 72288-698-10 Pain Relief 1. push down 2. Turn cap Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For up to 8 Hours Relief of Minor Muscle Aches and Pain 100 CAPLETS* *CAPSULE-SHAPED TABLETS DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Bottle) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton) amazon basic+care 8 Hour Muscle NDC 72288-698-10 Aches & Pain Compare to Tylenol ® 8HR Caplets active ingredient** Acetaminophen Extended-Release Tablets USP, 650 mg Pain Reliever/Fever Reducer For up to 8 Hours Relief of Minor Muscle Aches and Pain 100 CAPLETS* *CAPSULE-SHAPED TABLETS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton)

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
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.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat 40 o C (104 o F). do not use if carton is opened or foil inner seal is broken Meets USP dissolution test 3

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API