Acetaminophen ACETAMINOPHEN HEALTH PHARMA USA LLC FDA Approved Uses: temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain from arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M013
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Acetaminophen 325 mg
Inactive Ingredients
Inactive ingredients Pregelatinized Starch Polyvinyl Pyrrolidone Microcrystalline Cellulose Stearic acid powder Magnesium Stearate Hypromellose-5 & 15 Polyethylene Glycol-400 Talc Titanium Dioxide.
Strengths
325 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Muscular Aches Backache Minor Pain From Arthritis The Common Cold Toothache Premenstrual And Menstrual Cramps Temporarily Reduces Fever
Pill Appearance
Shape: round Color: white Imprint: S99

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1

Overview

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

Indications & Usage

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

Dosage & Administration

Directions adults and children 12 years and over: take 2 tablets every 4 to 6 hours while symptoms last do not take mote than 10 tablets in 24 hours, unless directed by doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years: take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by doctor

Warnings & Precautions
Warnings Liver warning : This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if: adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adults has 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.
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 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. 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.

Storage & Handling

Other information store between 20°-25°C (68°-77°F) read all product information before using TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Questions

Questions or comments? Call toll free 1-844-832-1138 Monday through Friday 9 AM - 5 PM EST


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