Acetaminophen ACETAMINOPHEN MARLEX PHARMACEUTICALS INC FDA Approved Uses Temporary 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
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Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each tablet) Ace taminophen USP 500 mg
Inactive Ingredients
Inactive Ingredients Pregelatinized Starch Povidone K 30 Sodium starch Glycolate Stearic Acid. Manufactured for/ Distributed by: Marlex Pharmaceuticals Inc. New Castle DE 19720 Rev. 01/26 AA
Strengths
500 mg
Treats Conditions
Uses Temporary 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
Pill Appearance
Shape: round Color: white Imprint: C;20

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

Principal Display Panel NDC 10135-0829-01 ACETAMINOPHEN 500 MG 829-01

Package Descriptions
  • Principal Display Panel NDC 10135-0829-01 ACETAMINOPHEN 500 MG 829-01

Overview

Uses Temporary 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

Indications & Usage

Uses Temporary 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

Dosage & Administration

Directions Do not take more than directed (see overdose warning) Adults and Children 12 years and over: Take 2 tablets every 6 hours while symptoms last. Do not take more than 6 tablets 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.

Warnings & Precautions
Warnings Liver warning : this product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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 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: Taking more than the recommended dose (overdose) may cause liver damage. 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.
Purpose

Purpose Pain Reliever/Fever Reducer

Do Not Use

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.

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

Keep out of reach of children.


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