Acetaminophen ACETAMINOPHEN CVS PHARMACY, INC. 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
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
ANDA207229

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts 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 Questions or comments? call 1-855-274-4122 Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket Rl 02895 ©2023 CVS/pharmacy CVS.com® 1-800-SHOP CVS Made in India Code: TS/DRUGS/22/2009
Strengths
650 mg
Quantities
225 tablet
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
UNII
362O9ITL9D
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablet Bottle) ♥ CVS Health ® Compare to the active ingredient in Tylenol ® 8HR Arthritis Pain * Tablets NDC 69842-037-35 8HR Arthritis Pain Relief ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain Actual Size TO OPEN: 1. PUSH DOWN 2. TURN CAP 225 EXTENDED- RELEASE TABLETS DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN figure 1

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablet Bottle) ♥ CVS Health ® Compare to the active ingredient in Tylenol ® 8HR Arthritis Pain * Tablets NDC 69842-037-35 8HR Arthritis Pain Relief ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg Pain Reliever/Fever Reducer For the temporary relief of minor arthritis pain Actual Size TO OPEN: 1. PUSH DOWN 2. TURN CAP 225 EXTENDED- RELEASE TABLETS DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN figure 1

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 use 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 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat 40 o C (104 o F). do not use if carton is opened or foil inner seal is broken Meets USP dissolution test 3


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