Topco Arthritis 8 Hour

Manufacturer
Topco Associates LLC | Ohm Laboratories Inc.
Effective date
2012-08-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:34:11

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: muscular aches headache minor pain of arthritis backache 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 and children 12 years and over 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 children under 12 years do not use

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 1-888-423-0139

PRINCIPAL DISPLAY PANEL

TopCare ® NDC 36800-228-01 FOR UP TO 8 HOUR RELIEF OF MINOR MUSCLE ACHES & PAIN Lasts up to 8 - Hour Pain Relief ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg Pain Reliever/Fever Reducer Use only as directed. DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN COMPARE TO TYLENOL ® 8 HOUR active ingredient †† 100 CAPLETS † 650 mg EACH ( † CAPSULE-SHAPED TABLETS) DISTRIBUTED BY TOPCO ASSOCIATES LLC 5095195/R512

Label Images

APAP
APAP

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: muscular aches headache minor pain of arthritis backache 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 and children 12 years and over 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 children under 12 years do not use

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 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

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 1-888-423-0139

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare ® NDC 36800-228-01 FOR UP TO 8 HOUR RELIEF OF MINOR MUSCLE ACHES & PAIN Lasts up to 8 - Hour Pain Relief ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg Pain Reliever/Fever Reducer Use only as directed. DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN COMPARE TO TYLENOL ® 8 HOUR active ingredient †† 100 CAPLETS † 650 mg EACH ( † CAPSULE-SHAPED TABLETS) DISTRIBUTED BY TOPCO ASSOCIATES LLC 5095195/R512

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otcAPAP.jpg2013-01-08
otcc9d94bfa-83e7-4f7a-b8c3-f74addd652ee.xml2013-01-08