FDA.reportPublic FDA data

Acetaminophen Tablets 500 mg

Manufacturer
Granules Pharmaceuticals Inc. | Granules India Limited
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:58:38

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure15 sections

Indications and 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

Dosage and administration

• 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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 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

Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take

• more than 4,000 mg of acetaminophen 24 hours.


• with other drugs containing acetaminophen

• 3 or more alcoholic drinks everyday while using this product

Allergy alert: acetaminophen may cause severe skin reactions.Symptoms may include:

• skin reddening

• blisters

• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

• with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

• if you are allergic to acetaminophen or any other inactive ingredients in this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask doctor if

OTC - STOP USE SECTION

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• new symptoms occur

• redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Over dose warning: In case of overdose, get medical help or Contact Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

SPL UNCLASSIFIED SECTION

• store at 20-25°C (68-77°F). See USP Controlled Room Temparature

• avoid high humidity


• See end panel for lot number and expiration date

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

hydroxyethyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

QUESTIONS OR COMMENTS ?

OTC - QUESTIONS SECTION

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

+All trademarkes are property of their reapective owners.

This product is not affliated with the makers/owners of

Extra Strength Tylenol ® Caplets.

Distributed by:

Granules Pharmaceuticals INc.,

Chantilly, VA 20151

MADE IN INDIA

Rev.08/21

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100-count-bottle-label100-count-bottle-label

100-count-bottle-carton-label100-count-bottle-carton-label

500-count-bottle-label500-count-bottle-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN5
198440acetaminophen 500 MG Oral TabletSCD5
198440APAP 500 MG Oral TabletSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-161-01ACETAMINOPHEN1 in 1 CARTONTABLET15
70010-161-01ACETAMINOPHEN100 in 1 BOTTLETABLET1005
70010-161-05ACETAMINOPHEN500 in 1 BOTTLETABLET5005
70010-161-10ACETAMINOPHEN1000 in 1 BOTTLETABLET10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-161ACETAMINOPHEN TABLET [GRANULES PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20250406_d5d49146-665e-4a93-e053-2995a90aca59.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-161-01EA - Each70010-1610ed1eb5c-3333-4e86-b023-551784d2efd312023-08-08
70010-161-05EA - Each70010-1612e1e4e0f-4cc6-437a-aa64-bf9985bbf91112023-08-08
70010-161-10EA - Each70010-16170fddc44-fb63-4964-a389-6514804206a812024-02-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70010-16170010-161-01, 70010-161-05, 70010-161-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHENACETAMINOPHENGranules Pharmaceuticals Inc.d5d49146-665e-4a93-e053-2995a90aca592025-04-02WarningsExact identifier
ndc (package): 70010-161-10
ndc (package): 70010-161-05
ndc (package): 70010-161-01
ndc (product): 70010-161
ndc11 (package): 70010016110
ndc11 (package): 70010016105
ndc11 (package): 70010016101
spl id: 31c4de05-74c3-ddc3-e063-6394a90a9388
spl set id: d5d49146-665e-4a93-e053-2995a90aca59

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.