Medicine Shoppe Arthritis Pain Reliever

Manufacturer
The Medicine Shoppe International | Ohm Laboratories Inc.
Effective date
2012-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:32:33

Key Label Information

Active Ingredients And Purpose

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

Uses

USES

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

Warnings

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

Directions And Dosage

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 U nder 18 years of age: ask a doctor

Other Label Information

INACTIVE INGREDIENTS

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

call 1-800-406-7984 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. ( for bottle cartons/label and stand-alone labels only) THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN. (for non CRC packages) Contains No Aspirin Keep the carton. It contains important information. Distributed by Medicine Shoppe International, Inc. Earth City, MO 63045 www.medicineshoppe.com 1-800-325-1397

PRINCIPAL DISPLAY PANEL

The Medicine Shoppe ® NDC 49614-473-78 Use only as directed. See New Warnings Information Lasts up to 8 hours Arthritis Pain Reliever Acetaminophen Extended-Release Tablets, USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN 100 CAPLETS * 650 mg EACH * Capsule-Shaped Tablets Compare to Tylenol ® Arthritis Pain active ingredient ** ** This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc. The owner of the registered trademark Tylenol ® is The Tylenol Company.

Label Images

APAPNew
APAPNew

Products

NDC Codes

Ingredients

Complete SPL Sections

ACTIVE INGREDIENT (IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 650 mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 U nder 18 years of age: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F). see end panel for batch number and expiration date

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

call 1-800-406-7984 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. ( for bottle cartons/label and stand-alone labels only) THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN. (for non CRC packages) Contains No Aspirin Keep the carton. It contains important information. Distributed by Medicine Shoppe International, Inc. Earth City, MO 63045 www.medicineshoppe.com 1-800-325-1397

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The Medicine Shoppe ® NDC 49614-473-78 Use only as directed. See New Warnings Information Lasts up to 8 hours Arthritis Pain Reliever Acetaminophen Extended-Release Tablets, USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN 100 CAPLETS * 650 mg EACH * Capsule-Shaped Tablets Compare to Tylenol ® Arthritis Pain active ingredient ** ** This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc. The owner of the registered trademark Tylenol ® is The Tylenol Company.

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/4059ab71-24fd-43dc-a9c9-c43956f5901f/deaaaeb4-2919-4131-916f-1ba2018cb5b5.xml
XML SHA-256
4462d255b9903fdcf47addb3976b594528feb8f4acedd03674e17cc0cb9bfeb4
XML bytes
31279

Legacy File Index

FolderFileDate
otcAPAPNew.jpg2012-07-13
otcdeaaaeb4-2919-4131-916f-1ba2018cb5b5.xml2012-07-13