FDA.reportPublic FDA data

Acetaminophen

Manufacturer
SAMJAN GROUP INC.
Effective date
2021-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:04

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure14 sections

Indications and uses

temporarily • relieves minor aches • reduces fever

Dosage and administration

• do not take more than directed This product does not contain directions or complete warnings for adult use. • find dose in chart below, if possible, use weight to dose, otherwise use age • dosage may be repeated every 4 hours as needed, or as directed by a doctor • do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoon Weight (lb) Under 24 24-36 36-47 48-59 60-71 72-95 age (yr) Under 2 2-3 4...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (per 5mL teaspoonful)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

Pain Reliever / Fever Reducer

Uses

INDICATIONS & USAGE SECTION

temporarily • relieves minor aches • reduces fever

Warnings

WARNINGS SECTION

Liver Warning: This product contains acetaminophen. Severe liver damage may

occur if your child takes: • more than 5 doses in 24 hours, which is the maximum

daily amount • taken with other drugs containing acetaminophen

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 your child is allergic to acetaminophen or any of

the inactive ingredients in this product

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has a liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product: Do not exceed recommended dose.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• pain gets worse or lasts more than 5 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed

This product does not contain directions or complete warnings for adult use.

• find dose in chart below, if possible, use weight to dose, otherwise use age

• dosage may be repeated every 4 hours as needed, or as directed by a doctor

• do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoon

Weight (lb)

Under 24

24-36

36-47

48-59

60-71

72-95

age (yr)

Under 2

2-3

4-5

6-8

9-10

11

Dosage (mL)

ask a doctor

5 mL

7.5 mL

10 mL

12.5 mL

15 mL

Other information

OTHER SAFETY INFORMATION

• each teaspoonful (5 mL) contains: sodium 7.9 mg

• store at room temperature 15°- 30°C (59°-86°F)

• protect from freezing • protect from light

• TAMPER-EVIDENT: Do not use if imprinted seal under cap is broken or missing.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

artificial cherry flavor, citric acid, FD&C Red #40, glycerin, PEG, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

• Compare To Active ingredient of Children's Tylenol

NDC 72091-004-01

Children's Liquid

Pain Reliever and Fever Reducer

Acetaminophen 160 mg/5mL

• Asprin Free

• Alcohol Free

• For Children Ages 2 - 11 years

Fruit Flavor

8 FL OZ (237 mL)

apapapap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN1
307675acetaminophen 32 MG/ML Oral SolutionSCD1
307675acetaminophen 160 MG per 5 ML Oral SolutionSY1
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY1
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY1
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY1
307675APAP 32 MG/ML Oral SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72091-004-012023-01-30C16284748780-1f386c649-a6e4-0266-e053-dadaa90a7c1abdc48d22-c606-665e-e053-2995a90a9dbe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72091-004-01Acetaminophen237 mL in 1 BOTTLELIQUID2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72091-004ACETAMINOPHEN LIQUID [SAMJAN GROUP INC.]1Legacy NDC, 1 package rows20210319_bdc48d22-c606-665e-e053-2995a90a9dbe.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72091-00472091-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
ACETAMINOPHEN362O9ITL9DACTIB
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
bdc48d22-c607-665e-e053-2995a90a9dbebdc48d22-c606-665e-e053-2995a90a9dbe2021-03-17WarningsExact identifier
spl id: bdc48d22-c607-665e-e053-2995a90a9dbe
spl set id: bdc48d22-c606-665e-e053-2995a90a9dbe

Reported adverse events (FAERS/openFDA)#

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