Acetaminophen ACETAMINOPHEN NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS FDA Approved Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
ANDA215486
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Acetaminophen 650 mg
Inactive Ingredients
Inactive ingredients carnauba wax hydroxyethylcellulose hypromellose povidone pregelatinized starch sodium starch glycolate magnesium stearate microcrystalline cellulose triacetin titanium dioxide
Strengths
650 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Minor Pain Of Arthritis Muscular Aches Backache Premenstrual And Menstrual Cramps The Common Cold Headache Toothache Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: white Imprint: 71

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

Principal Display Panel PRINCIPAL DISPLAY PANEL

Package Descriptions
  • Principal Display Panel PRINCIPAL DISPLAY PANEL

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets 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.
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. 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.


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