Acetaminophen 8 Hour

Manufacturer
Supervalu Inc. | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date
2013-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:49

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 1-877-932-7948

PRINCIPAL DISPLAY PANEL

equaline ® compare to Tylenol ® 8 Hour active ingredient * NDC 41163-336-01 use only as directed lasts up to 8 hours acetaminophen extended-release tablets, USP 650 mg 100 caplets ** pain reliever/fever reducer 650 mg each for up to 8 hour relief of minor muscle aches and pain ( ** capsule-shaped tablets) DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN DISTRIBUTED BY SUPERVALU INC. 5098570/R1012

Label Images

APAPArthritis8Hour
APAPArthritis8Hour

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 1-877-932-7948

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

equaline ® compare to Tylenol ® 8 Hour active ingredient * NDC 41163-336-01 use only as directed lasts up to 8 hours acetaminophen extended-release tablets, USP 650 mg 100 caplets ** pain reliever/fever reducer 650 mg each for up to 8 hour relief of minor muscle aches and pain ( ** capsule-shaped tablets) DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN DISTRIBUTED BY SUPERVALU INC. 5098570/R1012

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc858cc5c1-fa49-4d6b-98b4-608d507d03a2.xml2013-09-05
otcAPAPArthritis8Hour.jpg2013-09-05