FDA.reportPublic FDA data

AMAZON BASIC CARE ACETAMINOPHEN

Manufacturer
Amazon.com Services LLC | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2024-05-17
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:12:40

Label at a glance#

ProductAMAZON BASIC CARE ACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure16 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

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if carton is open or if printed foil seal under cap is torn or missing.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

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 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:

  • 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 drug 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 of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have 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 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a

health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a 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

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is open or if printed foil seal under cap is torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized starch (maize), stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-274-4122

DISTRIBUTED BY:
AMAZON.COM SERVICES LLC
410 TERRY AVENUE N.
SEATTLE, WA 98109

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Caplets Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

amazon
basic+care

Extra Strength
NDC 72288-692-10

See New Warnings Information
& Directions

Acetaminophen
Caplets 500 mg
Pain Reliever/Fever Reducer
For Adults
Contains No Aspirin

100 CAPLETS
500 mg EACH
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Caplets Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Caplets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Caplets Bottle Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

amazon
basic+care

Extra Strength
NDC 72288-692-10
Compare to
Extra Strength
Tylenol® Caplets
active ingredient*

See New Warnings Information & Directions

Acetaminophen
Caplets 500 mg
Pain Reliever/Fever Reducer
For Adults
Contains No Aspirin

100 CAPLETS
500 mg EACH


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Caplets Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Caplets Bottle)

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-692-01AMAZON BASIC CARE ACETAMINOPHEN1000 in 1 BOTTLETABLET10002
72288-692-10AMAZON BASIC CARE ACETAMINOPHEN100 in 1 BOTTLETABLET1002
72288-692-10AMAZON BASIC CARE ACETAMINOPHEN1 in 1 CARTONTABLET12
72288-692-20AMAZON BASIC CARE ACETAMINOPHEN200 in 1 BOTTLETABLET2002
72288-692-50AMAZON BASIC CARE ACETAMINOPHEN500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-692AMAZON BASIC CARE ACETAMINOPHEN (ACETAMINOPHEN) TABLET [AMAZON.COM SERVICES LLC]2Current NDC, 5 package rows20240518_10ee2f40-858d-bed4-e063-6394a90a86bb.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72288-69272288-692-10, 72288-692-20, 72288-692-50, 72288-692-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
PALMITOSTEARIC ACIDQ8Y7S3B85MIACT

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
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC10ee2f40-858d-bed4-e063-6394a90a86bb2024-05-17WarningsExact identifier
ndc (package): 72288-692-01
ndc (package): 72288-692-20
ndc (package): 72288-692-50
ndc (package): 72288-692-10
ndc (product): 72288-692
ndc11 (package): 72288069210
ndc11 (package): 72288069201
ndc11 (package): 72288069220
ndc11 (package): 72288069250
spl id: 01c0b452-c626-4d2c-8e67-e4c9750195ff
spl set id: 10ee2f40-858d-bed4-e063-6394a90a86bb

Reported adverse events (FAERS/openFDA)#

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