Extra Strength Acetaminophen Tablets

Set ID
3f9c230b-e6ea-4786-992b-9c7204425209
Manufacturer
CVS PHARMACY, INC. | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2017-11-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:56

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Uses

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

Warnings

Warnings

Directions And Dosage

Directions

do not take more than directed (see Overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Other Label Information

Other information

Store the product at controlled room temperature 15°-30°C (59°-86°F). Protect from light, moisture and freezing.

Inactive ingredients

hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid powder, talc, titanium dioxide

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

CVS Extra Strength Acetaminophen Tablets, 500 mg NDC 69842-390-54

Products

NDC Codes

Ingredients

NameUNIIKind
Acetaminophen362O9ITL9DACTIB
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
POVIDONEFZ989GH94EIACT
hypromellose, unspecified3NXW29V3WOIACT
magnesium stearate70097M6I30IACT
polyethylene glycol, unspecified3WJQ0SDW1AIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
titanium dioxide15FIX9V2JPIACT

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see Overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

Store the product at controlled room temperature 15°-30°C (59°-86°F). Protect from light, moisture and freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid powder, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Extra Strength Acetaminophen Tablets, 500 mg NDC 69842-390-54

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML SHA-256
c032f1e55fe17dec092a05136e292bb1f46d2a0252db67f6af760a6141b8414a
XML bytes
28966

Legacy File Index

FolderFileDate
otc8e71c727-66ab-497b-ad8e-0230b43f9a1d.xml2017-11-10
otcCVS31-00-back.jpg2017-11-10
otcCVS31-00-front.jpg2017-11-10
otcCVSB30-00.jpg2017-11-10
otcCVSF30-00.jpg2017-11-10