acetaminophen oral solution usp

SPL v8

SPL

SPL Set ID e13656eb-513e-411e-bdae-35ff1ba7cfc1

Route

oral

Published

Effective Date 2025-03-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

acetaminophen (650 mg)

Inactive Ingredients

anhydrous citric acid fd&c red no. 40 glycerin polyethylene glycol, unspecified propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol sucrose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

otc monograph drug active Since 2007-08-01

Purpose

Pain reliever/fever reducer

Description

ACETAMINOPHEN 160 mg

Medication Information

Uses

temporarily relieves minor aches and pains due to:

•
headache
•
muscular aches
•
backache
•
minor pain of arthritis
•
the common cold
•
toothache
•
premenstrual and menstrual cramps

temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

▪
do not take more than directed (see overdose warning)

age	dose
adults and children 12 years of age and over	20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age	10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age	7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age	5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children under 2 years of age	consult a doctor

Other Information

■ Each 5 mL contains: sodium 2 mg

■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

■ keep tightly closed ■ protect from light

■ a red, cherry flavored solution supplied in the following oral dosage forms:

Overbagged with 5 x 20.3 mL unit dose cups per bag, NDC 55154-9449-5

Description

ACETAMINOPHEN 160 mg

Principal Display Panel

NDC 55154-9449-5

ACETAMINOPHEN ORAL SOLUTION USP

650 mg / 20.3 mL

5 CUPS

Section 42229-5

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

▪
adult takes more than 6 doses in 24 hours, which is the maximum daily amount
▪
child takes more than 5 doses in 24 hours
▪
taken with other drugs containing acetaminophen
▪
adult has 3 or more alcoholic drinks every day while using this product

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.

Section 50569-3

Ask a doctor before use if the user has liver disease

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warning:

This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

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 of this product

Manufactured By:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L53336120225

R10/20

Active Ingredient

ACETAMINOPHEN 160 mg

Inactive Ingredients:

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Questions Or Comments?

Call 1-800-845-8210. You may also report serious side effects to this phone number.

Stop Use and Ask A Doctor If

•
symptoms do not improve
•
new symptoms occur
•
pain or fever persists or gets worse

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

•
headache
•
muscular aches
•
backache
•
minor pain of arthritis
•
the common cold
•
toothache
•
premenstrual and menstrual cramps

temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

▪
do not take more than directed (see overdose warning)

age	dose
adults and children 12 years of age and over	20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period
children 6 to under 12 years of age	10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 4 to under 6 years of age	7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children 2 to under 4 years of age	5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period
children under 2 years of age	consult a doctor

Other Information (Other information)

■ Each 5 mL contains: sodium 2 mg

■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

■ keep tightly closed ■ protect from light

■ a red, cherry flavored solution supplied in the following oral dosage forms:

Overbagged with 5 x 20.3 mL unit dose cups per bag, NDC 55154-9449-5

Principal Display Panel

NDC 55154-9449-5

ACETAMINOPHEN ORAL SOLUTION USP

650 mg / 20.3 mL

5 CUPS

Section 42229-5 (42229-5)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

▪
adult takes more than 6 doses in 24 hours, which is the maximum daily amount
▪
child takes more than 5 doses in 24 hours
▪
taken with other drugs containing acetaminophen
▪
adult has 3 or more alcoholic drinks every day while using this product

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if the user has liver disease

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Warning: (WARNING:)

This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Do Not Use (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 of this product

Manufactured By: (MANUFACTURED BY:)

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L53336120225

R10/20

Active Ingredient (Active ingredient)

ACETAMINOPHEN 160 mg

Inactive Ingredients: (Inactive ingredients:)

Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210. You may also report serious side effects to this phone number.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

•
symptoms do not improve
•
new symptoms occur
•
pain or fever persists or gets worse

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • the common cold • toothache • premenstrual and menstrual cramps temporarily reduces fever", "42229-5": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if: ▪ adult takes more than 6 doses in 24 hours, which is the maximum daily amount ▪ child takes more than 5 doses in 24 hours ▪ taken with other drugs containing acetaminophen ▪ adult has 3 or more alcoholic drinks every day while using this product", "50565-1": "Keep out of reach of children.", "50568-5": "Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.", "50569-3": "Ask a doctor before use if the user has liver disease", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Pain reliever/fever reducer", "WARNING:": "This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.", "Directions": "▪ do not take more than directed (see overdose warning ) age dose adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children 6 to under 12 years of age 10.15 mL (325 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 4 to under 6 years of age 7.5 mL (240 mg) every 4 hours not to exceed 5 doses in a 24-hour period children 2 to under 4 years of age 5 mL (160 mg) every 4 hours not to exceed 5 doses in a 24-hour period children under 2 years of age consult a doctor", "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 of this product", "MANUFACTURED BY:": "Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com Distributed By: Cardinal Health Dublin, OH 43017 L53336120225 R10/20", "Active ingredient": "ACETAMINOPHEN 160 mg", "Other information": "■ Each 5 mL contains: sodium 2 mg ■ store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] ■ keep tightly closed ■ protect from light ■ a red, cherry flavored solution supplied in the following oral dosage forms: Overbagged with 5 x 20.3 mL unit dose cups per bag, NDC 55154-9449-5", "Inactive ingredients:": "Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.", "Questions or comments?": "Call 1-800-845-8210. You may also report serious side effects to this phone number.", "Principal Display Panel": "NDC 55154-9449-5 ACETAMINOPHEN ORAL SOLUTION USP 650 mg / 20.3 mL 5 CUPS", "Stop use and ask a doctor if": "• symptoms do not improve • new symptoms occur • pain or fever persists or gets worse"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:41.752584 · Updated: 2026-03-14T23:07:53.934759