Arthritis 8 Hour

Manufacturer
Safeway Inc. | Ohm Laboratories Inc.
Effective date
2012-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:07

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 backache headache toothache minor pain of arthritis 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 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 1-800-406-7984

PRINCIPAL DISPLAY PANEL

8 Hour Use only as directed. NDC 21130-336-01 Pain Relief Compare to Tylenol ® 8 Hour active ingredient † Acetaminophen Extended-Release Tablets, USP Pain Reliever/Fever Reducer For up to 8 Hour Relief of Minor Muscle Aches & Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 100 CAPLETS * 650 mg EACH ( * capsule-shaped tablets) SAFEWAY ® DISTRIBUTED BY SAFEWAY INC. 5091297/R1011

Label Images

APAP8Hour
APAP8Hour

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 backache headache toothache minor pain of arthritis 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 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 1-800-406-7984

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 Hour Use only as directed. NDC 21130-336-01 Pain Relief Compare to Tylenol ® 8 Hour active ingredient † Acetaminophen Extended-Release Tablets, USP Pain Reliever/Fever Reducer For up to 8 Hour Relief of Minor Muscle Aches & Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 100 CAPLETS * 650 mg EACH ( * capsule-shaped tablets) SAFEWAY ® DISTRIBUTED BY SAFEWAY INC. 5091297/R1011

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc106ff398-7ae3-4eae-bd7d-a8ac2e0254fd.xml2012-09-27
otcAPAP8Hour.jpg2012-09-27