Acetaminophen Oral Solution Usp

SPL v2

SPL

SPL Set ID 0d6553bd-3e18-4624-a83a-899bcafb3272

Route

ORAL

Published

Effective Date 2023-06-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 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 2023-07-28

Description

Pain reliever/fever reducer

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Pain reliever/fever reducer

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

Section 42229-5

DO NOT USE IF SEAL IS BROKEN.

Distributed by:

American Health Packaging

Columbus, OH 43217

R03/23

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 thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you have

liver disease

Section 53414-9

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

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 under 6 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

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.

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

adult takes more than 10 unit dose cups in 24 hours, which is the maximum daily amount
child takes more than 5 unit dose cups in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Active Ingredient

Acetaminophen 325 mg

Other Information

Each 10.15 mL contains: sodium 4 mg
store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
protect from light
a red, cherry flavored solution supplied in the following oral dosage forms:

10.15 mL unit dose cups: 100 cups (10 x 10) NDC 60687-751-56

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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 children even if you do not notice any signs or symptoms.

Sore Throat Warning:

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.

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

Principal Display Panel – Tray Label

Case NDC 60687-751-56/Cup NDC 60687-751-42

ACETAMINOPHEN

ORAL SOLUTION USP

325 mg/10.15 mL

ALCOHOL FREE

Each 10.15 mL contains:

Acetaminophen 325 mg

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

For Institutional Use Only.

T0657C110323 R03/23

Principal Display Panel – Cup – 325 Mg / 10.15 Ml

NDC 60687- 751-42

ACETAMINOPHEN

ORAL SOLUTION USP

Pain Reliever/Fever Reducer

325 mg/10.15 mL

ALCOHOL FREE

Delivers 10.15 mL

Protect from light.

See packaging Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0657C110323

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

Section 42229-5 (42229-5)

DO NOT USE IF SEAL IS BROKEN.

Distributed by:

American Health Packaging

Columbus, OH 43217

R03/23

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 thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

liver disease

Section 53414-9 (53414-9)

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

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 under 6 years of age	consult a doctor

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

Allergy Alert: (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.

Liver Warning: (Liver warning:)

This product contains acetaminophen. Severe liver damage may occur if you take:

adult takes more than 10 unit dose cups in 24 hours, which is the maximum daily amount
child takes more than 5 unit dose cups in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Active Ingredient (Active ingredient)

Acetaminophen 325 mg

Other Information (Other information)

Each 10.15 mL contains: sodium 4 mg
store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
protect from light
a red, cherry flavored solution supplied in the following oral dosage forms:

10.15 mL unit dose cups: 100 cups (10 x 10) NDC 60687-751-56

Overdose Warning: (Overdose warning:)

Sore Throat Warning: (Sore throat warning:)

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.

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

Principal Display Panel – Tray Label

Case NDC 60687-751-56/Cup NDC 60687-751-42

ACETAMINOPHEN

ORAL SOLUTION USP

325 mg/10.15 mL

ALCOHOL FREE

Each 10.15 mL contains:

Acetaminophen 325 mg

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

For Institutional Use Only.

T0657C110323 R03/23

Principal Display Panel – Cup – 325 Mg / 10.15 Ml (Principal Display Panel – Cup – 325 mg / 10.15 mL)

NDC 60687- 751-42

ACETAMINOPHEN

ORAL SOLUTION USP

Pain Reliever/Fever Reducer

325 mg/10.15 mL

ALCOHOL FREE

Delivers 10.15 mL

Protect from light.

See packaging Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0657C110323

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": "DO NOT USE IF SEAL IS BROKEN. Distributed by: American Health Packaging Columbus, OH 43217 R03/23", "50565-1": "Keep out of reach of children.", "50568-5": "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.", "50569-3": "Ask a doctor before use if you have liver disease", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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 under 6 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", "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.", "Liver warning:": "This product contains acetaminophen. Severe liver damage may occur if you take: adult takes more than 10 unit dose cups in 24 hours, which is the maximum daily amount child takes more than 5 unit dose cups in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product", "Active ingredient": "Acetaminophen 325 mg", "Other information": "Each 10.15 mL contains: sodium 4 mg store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] protect from light a red, cherry flavored solution supplied in the following oral dosage forms: 10.15 mL unit dose cups: 100 cups (10 x 10) NDC 60687-751-56", "Overdose warning:": "Taking more than the recommended dose (overdose) may cause liver damage. 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 children even if you do not notice any signs or symptoms.", "Sore throat warning:": "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.", "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", "Principal Display Panel – Tray Label": "Case NDC 60687-751-56/Cup NDC 60687-751-42 ACETAMINOPHEN ORAL SOLUTION USP 325 mg/10.15 mL ALCOHOL FREE Each 10.15 mL contains: Acetaminophen 325 mg USUAL DOSAGE: See attached Drug Facts Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. For Institutional Use Only. T0657C110323 R03/23", "Principal Display Panel – Cup – 325 mg / 10.15 mL": "NDC 60687- 751 -42 ACETAMINOPHEN ORAL SOLUTION USP Pain Reliever/Fever Reducer 325 mg/10.15 mL ALCOHOL FREE Delivers 10.15 mL Protect from light. See packaging Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0657C110323"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:55.230937 · Updated: 2026-03-14T23:04:16.644897