Acetaminophen 325mg ACETAMINOPHEN MARLEX PHARMACEUTICALS INC FDA Approved Uses To reduce fever and for the temporary relief of minor aches and pains due to: Headache Backache The common cold Premenstrual and menstrual cramps Temporarily reduces fever Muscular ache Minor pain of arthritis Toothache
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Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each tablet) Acetaminophen USP 325 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
325 mg
Quantities
100 tablets
Treats Conditions
Uses To Reduce Fever And For The Temporary Relief Of Minor Aches And Pains Due To Headache Backache The Common Cold Premenstrual And Menstrual Cramps Temporarily Reduces Fever Muscular Ache Minor Pain Of Arthritis Toothache
Pill Appearance
Shape: round Color: white Imprint: C;19

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL NDC 10135-0828-01 Acetaminophen 325 mg 100 TABLETS 828-01

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 10135-0828-01 Acetaminophen 325 mg 100 TABLETS 828-01

Overview

Uses To reduce fever and for the temporary relief of minor aches and pains due to: Headache Backache The common cold Premenstrual and menstrual cramps Temporarily reduces fever Muscular ache Minor pain of arthritis Toothache

Indications & Usage

Uses To reduce fever and for the temporary relief of minor aches and pains due to: Headache Backache The common cold Premenstrual and menstrual cramps Temporarily reduces fever Muscular ache Minor pain of arthritis Toothache

Dosage & Administration

Directions Do not take m ore than directed Adults and Children 12 years and over: Take 2 tablets every 4 to 6 hours while symptoms last. Do not take more than 12 tablets in 24 hours Children 6-11 years: Take 1 tablet every 4 to 6 hours while symptoms last. Do not take more than 5 tablets in 24 hours. Children under 6 years: Do not use this adult regular strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Warnings & Precautions
Warnings Liver warning : this product contains acetaminophen. Severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount child takes more than 5 doeses in 24 hours taken with other drugs containing acetaminophen adult has 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 p harmacist 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 in adults and children. Pain gets worse or lasts more than 5 days in children under 12 years. 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 in adults and children. Pain gets worse or lasts more than 5 days in children under 12 years. 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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