Acetaminophen 8 Hour

Manufacturer
CVS Pharmacy | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date
2013-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:34:49

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 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, 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 1-800-406-7984

PRINCIPAL DISPLAY PANEL

CVS pharmacy ® Compare to the active ingredient in Tylenol ® 8 Hour † Use only as directed. See New Warnings Information Lasts up to 8 Hour GLUTEN FREE DYE FREE PAIN RELIEF CAPLETS * ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg Pain Reliever/Fever Reducer For up to 8 Hour Relief of Minor Muscular Aches & Pain 100 CAPLETS * 650 mg EACH DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN ( * Capsule-Shaped Tablets) Distributed by: CVS Pharmacy, Inc. 5095677/R0512

Label Images

APAP8Hr
APAP8Hr

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 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, 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 1-800-406-7984

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS pharmacy ® Compare to the active ingredient in Tylenol ® 8 Hour † Use only as directed. See New Warnings Information Lasts up to 8 Hour GLUTEN FREE DYE FREE PAIN RELIEF CAPLETS * ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg Pain Reliever/Fever Reducer For up to 8 Hour Relief of Minor Muscular Aches & Pain 100 CAPLETS * 650 mg EACH DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN ( * Capsule-Shaped Tablets) Distributed by: CVS Pharmacy, Inc. 5095677/R0512

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc59d0f3f6-06f2-43f1-b220-4eedeb32e663.xml2013-03-07
otcAPAP8Hr.jpg2013-03-07