FDA.reportPublic FDA data

Acetaminophen

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2021-05-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:04:40

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains associated with: the common cold flu sore throat headache toothache and to reduce fever

Dosage and administration

this product does not contain directions or complete warnings for adult use use only the enclosed dosing cup designed for use with this product if possible, use weight to dose, otherwise use age dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor Weight (lbs.) Age (years) Dosage Teaspoonful (tsp) or as directed by a doctor Under 24 Under 2 Consult a doctor ...

Storage and handling

Each 5 mL contains: Sodium 3 mg If dispensed, dispense in a tight, light resistant container with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with:

  • the common cold
  • flu
  • sore throat
  • headache
  • toothache
  • and to reduce fever

Warnings

WARNINGS SECTION

Liver Warning

SPL UNCLASSIFIED SECTION

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
  • with other drugs that contain acetaminophen

Allergy alert

SPL UNCLASSIFIED SECTION

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.

Sore throat warning

SPL UNCLASSIFIED SECTION

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if your child is taking the blood thinning drug warfarin.

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
  • redness or swelling is present
  • any new symptoms appear.

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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

  • this product does not contain directions or complete warnings for adult use
  • use only the enclosed dosing cup designed for use with this product
  • if possible, use weight to dose, otherwise use age
  • dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor
Weight (lbs.)Age (years)Dosage Teaspoonful (tsp)*
Under 24Under 2Consult a doctor
24 to 352 to under 45 mL (1 tsp)
36 to 474 to under 67.5 mL (1 1/2 tsp)
48 to 596 to under 910 mL (2 tsp)
60 to 719 to under 1112.5 mL (2 1/2 tsp)
72 to 9511 to under 1215 mL (3 tsp)

* or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • Each 5 mL contains: Sodium 3 mg
  • If dispensed, dispense in a tight, light resistant container with a child-resistant cap.
  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution, Sucralose.

Questions?

OTC - QUESTIONS SECTION

You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-221-7294 or FDA at 1-800-FDA-1088.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69367-323-04

Children's
Acetaminophen
Liquid

160 mg/5 mL

Pain Reliever / Fever Reducer
Sugar Free / Alcohol Free
Aspirin Free
CHERRY FLAVOR

4 fl. oz. (118 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN6
307675acetaminophen 32 MG/ML Oral SolutionSCD6
307675acetaminophen 160 MG per 5 ML Oral SolutionSY6
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY6
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY6
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY6
307675APAP 32 MG/ML Oral SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-323-04Acetaminophen118 mL in 1 BOTTLE, PLASTICLIQUID1186
69367-323-16Acetaminophen473 mL in 1 BOTTLE, PLASTICLIQUID4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-323ACETAMINOPHEN LIQUID [WESTMINSTER PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20231216_ace5ebac-ec11-4c26-b1e3-954b450ee671.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-323-04ML - Milliliter69367-3231487bbd4-bc3f-4001-8463-bb79d06ce05512021-07-15
69367-323-16ML - Milliliter69367-3232f44c9ce-a538-45d0-924d-9e97b20b854012021-07-15

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
69367-32369367-323-04, 69367-323-16

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
ACETAMINOPHEN362O9ITL9DACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
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
AcetaminophenACETAMINOPHENWestminster Pharmaceuticals, LLCace5ebac-ec11-4c26-b1e3-954b450ee6712021-05-04WarningsExact identifier
ndc (package): 69367-323-04
ndc (package): 69367-323-16
ndc (product): 69367-323
ndc11 (package): 69367032316
ndc11 (package): 69367032304
spl id: f382f280-b5cf-4f4b-869b-285ed012c19e
spl set id: ace5ebac-ec11-4c26-b1e3-954b450ee671

Reported adverse events (FAERS/openFDA)#

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