Acetaminophen ACETAMINOPHEN CVS PHARMACY, INC. FDA Approved Uses temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
ANDA207229
Package NDC

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 RI 02895 © 2023 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Made in India Code: TS/DRUGS/22/2009
Strengths
650 mg
Quantities
24 tablets 24 tablet 150 tablets
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Muscular Aches Backache Minor Pain Of Arthritis Toothache Premenstrual And Menstrual Cramps Headache The Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: white Imprint: I;06

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
362O9ITL9D
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Bottle) CVSHealth ® Tablets NDC 69842-635-07 8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever/Fever Reducer DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 24 EXTENDED-RELEASE TABLETS 650 mg EACH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablet Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton) CVS Health ® Compare to the active ingredient in Tylenol ® 8HR Muscle Aches & Pain* Tablets NDC 69842-635-07 8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever/Fever Reducer For up to 8 hours of relief of minor muscle aches & pain Contains No Aspirin 24 EXTENDED-RELEASE TABLETS 650 mg EACH DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (150 Tablets Container Carton)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Bottle) CVSHealth ® Tablets NDC 69842-635-07 8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever/Fever Reducer DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 24 EXTENDED-RELEASE TABLETS 650 mg EACH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablet Bottle)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (24 Tablets Container Carton) CVS Health ® Compare to the active ingredient in Tylenol ® 8HR Muscle Aches & Pain* Tablets NDC 69842-635-07 8HR Muscle Aches & Pain ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg Pain Reliever/Fever Reducer For up to 8 hours of relief of minor muscle aches & pain Contains No Aspirin 24 EXTENDED-RELEASE TABLETS 650 mg EACH DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (150 Tablets Container Carton)

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed (see overdose warning). adults and children 12 years and over 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. children under 12 years do not use

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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