Acetaminophen Caplets

Manufacturer
Breeden Brothers, LLC
Effective date
2017-02-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:56:55

Label at a glance#

ProductAcetaminophen Caplets
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and uses

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

Dosage and administration

_ do not take more than directed _ 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 take for more than 10 days unless directed by a doctor _ children under 12 years: ask a doctor

Label contents#

Full prescribing information#

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

Drug Facts (continued)

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe

liver damage may occur if you take

_ more than 4,000 mg of acetaminophen in 24 hours

_ with other drugs containing acetaminophen

_ 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include: _ rash _ blisters

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

Do not use

OTC - DO NOT USE SECTION

_ if you are allergic to acetaminophen or any of the inactive ingredients in this product

_ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug

Drug Facts (continued)

contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have liver disease.

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking the blood thinning drug warfarin.

Stop use and ask a 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

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is

Drug Facts (continued)

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

_ 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 take for more than 10 days unless directed by a doctor

_ children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

_ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

_ use by expiration date on package

Drug Facts (continued)

Inactive ingredients

INACTIVE INGREDIENT SECTION

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-901-2420

Dist. by Breeden Brothers, LLC
Nashville, TN 37219

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

b+b
better by giving
EXTRA STRENGTH
PAIN RELIEVER
acetaminophen
Pain Reliever/Fever Reducer
50 Caplets
(500 mg each)

PRINCIPAL DISPLAY PANEL b+b better by giving EXTRA STRENGTH PAIN RELIEVER acetaminophen Pain Reliever/Fever Reducer 50 Caplets (500 mg each)PRINCIPAL DISPLAY PANEL b+b better by giving EXTRA STRENGTH PAIN RELIEVER acetaminophen Pain Reliever/Fever Reducer 50 Caplets (500 mg each)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

b+b
NDC 70729-175-12
EXTRA STRENGTH
PAIN RELIEVER
acetaminophen 500 mg
Pain Reliever/Fever Reducer
100 Caplets

b+b NDC 70729-175-12 EXTRA STRENGTH PAIN RELIEVER acetaminophen 500 mg Pain Reliever/Fever Reducer 100 Capletsb+b NDC 70729-175-12 EXTRA STRENGTH PAIN RELIEVER acetaminophen 500 mg Pain Reliever/Fever Reducer 100 Caplets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70729-001-24Acetaminophen Caplets24 in 1 BOTTLE, PLASTICTABLET242
70729-001-50Acetaminophen Caplets50 in 1 BOTTLE, PLASTICTABLET502
70729-175-12Acetaminophen Caplets100 in 1 BOTTLE, PLASTICTABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70729-001ACETAMINOPHEN CAPLETS (ACETAMINOPHEN) TABLET [BREEDEN BROTHERS, LLC]2Current NDC, Legacy NDC, 2 package rows20180929_57fff3dc-ba30-4d3d-9362-01df6974f813.zip
70729-175ACETAMINOPHEN CAPLETS (ACETAMINOPHEN) TABLET [BREEDEN BROTHERS, LLC]2Current NDC, Legacy NDC, 1 package rows20180929_57fff3dc-ba30-4d3d-9362-01df6974f813.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70729-00170729-001-24, 70729-001-50
70729-17570729-175-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
Acetaminophen CapletsACETAMINOPHENBreeden Brothers, LLC57fff3dc-ba30-4d3d-9362-01df6974f8132017-02-15WarningsExact identifier
ndc (package): 70729-001-24
ndc (package): 70729-001-50
ndc (package): 70729-175-12
ndc (product): 70729-001
ndc (product): 70729-175
ndc11 (package): 70729000124
ndc11 (package): 70729000150
ndc11 (package): 70729017512
spl id: 62ddc12d-7480-4db8-a784-e2e1503fad2b
spl set id: 57fff3dc-ba30-4d3d-9362-01df6974f813

Reported adverse events (FAERS/openFDA)#

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