Arthritis Pain Reliever Extended Release ACETAMINOPHEN P & L DEVELOPMENT, LLC FDA Approved Uses temporarily relieves minor aches and pains due to: minor pain of arthritis backache muscular aches toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
ANDA211544
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Acetaminophen USP 650 mg
Inactive Ingredients
Inactive ingredients hydroxyethyl cellulose hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol povidone pregelatinized starch sodium starch glycolate stearic acid
Strengths
650 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Minor Pain Of Arthritis Backache Muscular Aches Toothache Premenstrual And Menstrual Cramps Headache The Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: white Imprint: G650

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0359726013109
UNII
362O9ITL9D
Packaging

Principal Display Panel Compare to the active ingredient in Tylenol® 8HR Arthritis Pain † see new warning arthritis pain reliever acetaminophen extended-release tablets USP, 650 mg pain reliever/fever reducer for the temporary relief of minor arthritis pain contains no aspirin caplets* (*capsule-shaped bi-layer tablets) †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Arthritis Pain. TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: PL Developments 200 Hicks Street Westbury, NY 11590; Product Label READYinCASE Arthritis Pain Reliever Acetaminophen USP, 650 mg

Package Descriptions
  • Principal Display Panel Compare to the active ingredient in Tylenol® 8HR Arthritis Pain † see new warning arthritis pain reliever acetaminophen extended-release tablets USP, 650 mg pain reliever/fever reducer for the temporary relief of minor arthritis pain contains no aspirin caplets* (*capsule-shaped bi-layer tablets) †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Arthritis Pain. TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: PL Developments 200 Hicks Street Westbury, NY 11590
  • Product Label READYinCASE Arthritis Pain Reliever Acetaminophen USP, 650 mg

Overview

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

Indications & Usage

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis backache muscular aches 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 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 ever 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 a medical help right away. 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 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 (1-800-222-1222) right away. 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)

Questions

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST


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