Acetaminophen ACETAMINOPHEN BLUEPOINT LABORATORIES 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
ANDA207229
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each extended release tablet) Acetaminophen USP 650 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide hydroxyethyl cellulose hypromellose magnesium stearate microcrystalline cellulose povidone pregelatinized starch (maize) sodium starch glycolate titanium dioxide triacetin
Strengths
650 mg
Quantities
100 tablets
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: I;06

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0368001495004
UNII
362O9ITL9D
Packaging

Package Label - Principal Display Panel Acetaminophen Extended-Release tablets USP 650mg (100 tablets Carton) NDC: 68001-495-00 Acetaminophen Extended-Release tablets USP 650mg (100 tablets Container Label) NDC: 68001-495-00 Carton Label

Package Descriptions
  • Package Label - Principal Display Panel Acetaminophen Extended-Release tablets USP 650mg (100 tablets Carton) NDC: 68001-495-00 Acetaminophen Extended-Release tablets USP 650mg (100 tablets Container Label) NDC: 68001-495-00 Carton Label

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 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. 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 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.
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. Ask a doctor before ue if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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. If pregnant or breast-feeding, ask a health professional before use.

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 at 20º to 25ºC (68º to 77ºF). Avoid excessive heat 40ºC (104ºF) do not use if carton is opened or foil inner seal is broken USP Dissolution test is pending

Questions

Questions or comments? call 1-855-274-4122 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ), Mahabubnagar (Dt)-509302, India. For BluePoint Laboratories Rev: 03/2021 M.L. No.: 22/MN/AP/2009/F/R


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