Acetaminophen

Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2022-11-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:51:27

Label at a glance#

ProductAcetaminophen

Active ingredientACETAMINOPHEN

Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches backache arthritis the common cold toothache menstrual cramps reduces fever

Dosage and administration

Do not exceed recommended dosage. Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage. adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Storage and handling

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)

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

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

temporarily relieves minor aches and pains due to:

headache
muscular aches
backache
arthritis
the common cold
toothache
menstrual cramps
reduces fever

Warnings

WARNINGS SECTION

Liver Warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen.

Severe liver damage may occur if you take:

more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have health issues especially liver disease.

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking other drugs, including the blood thinner warfarin.

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.

for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Stop use and ask a doctor if

OTC - STOP USE SECTION

new symptoms occur such as rash, hives, itching or hoarseness
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
symptoms do not improve

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.

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 even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed recommended dosage.

Overdose Warnings

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.

adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.

Other information

STORAGE AND HANDLING SECTION

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

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

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL -

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	1
307675	acetaminophen 32 MG/ML Oral Solution	SCD	1
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	1
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	1
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	1
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	1
307675	APAP 32 MG/ML Oral Solution	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2870-4	2025-01-30	C162847	48780-1	2cef2736-690a-d83d-e063-dadaa90ab31f	Acetaminophen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2870-4	Acetaminophen	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2870	ACETAMINOPHEN LIQUID [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20221109_ecf95a39-7b34-560b-e053-2a95a90af2ac.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69367-323-04	ML - Milliliter	69367-323	1487bbd4-bc3f-4001-8463-bb79d06ce055	1	2021-07-15
69367-323-16	ML - Milliliter	69367-323	2f44c9ce-a538-45d0-924d-9e97b20b8540	1	2021-07-15

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Acetaminophen
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SACCHARIN SODIUM
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-2870	68071-2870-4
69367-323

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
TRISODIUM CITRATE DIHYDRATE	B22547B95K	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ecf96b50-744b-7a12-e053-2995a90a9286			ecf95a39-7b34-560b-e053-2a95a90af2ac	2022-11-08	Warnings	Exact identifier spl id: ecf96b50-744b-7a12-e053-2995a90a9286 spl set id: ecf95a39-7b34-560b-e053-2a95a90af2ac
Acetaminophen	ACETAMINOPHEN	Westminster Pharmaceuticals, LLC	ace5ebac-ec11-4c26-b1e3-954b450ee671	2021-05-04	Warnings	Exact identifier ndc (product): 69367-323

Reported adverse events (FAERS/openFDA)#

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