Acetaminophen Oral Solution Usp

SPL v2

SPL

SPL Set ID 355a094c-bed9-4959-8cf0-619f0e246105

Route

ORAL

Published

Effective Date 2025-12-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Glycerin Polyethylene Glycol 400 Water Sodium Benzoate Sodium Metabisulfite Sorbitol Sucralose Sodium Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-09

Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

Uses

• for the temporary relief of minor aches and pains due to

headache
muscular aches
backache
sore throat
flu
the common cold
toothache
premenstrual and menstrual cramps

• for the minor pain from arthritis

• and to reduce fever

Section 34088-5

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.

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 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 the user

• has liver disease

• is a child with pain of arthritis

Section 51727-6

Inactive ingredients anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate

Section 53414-9

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

Purposes

Pain reliever/fever reducer

Directions

do not take more than directed (see overdose warning)
dose product from the single dose cup the product is packaged in
mL=milliliter

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
if you are allergic to aetaminophen or any of the inactive ingredients of this product

Distributed by:

PAI Pharma

Greenville,SC 29605

www.paipharma.com

R05/25

Active Ingredient

Acetaminophen 325 mg

Other Information

■ Each 10.15 mL contains: sodium 12 mg

■ store at 20° to 25°C (68° to 77°F)

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

adult's pain gets worse or lasts more than 10 days
child's 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

Principal Display Panel 10.15 Ml Cup

Delivers 10.15 mL

NDC 0121-2094-11

Acetaminophen

Oral Solution USP

325 mg/10.15 mL

Pain Reliever/Fever Reducer

Alcohol Free/Dye Free/Sugar Free

Grape Flavored

Package Not Child-Resistant

Dist. by: PAI Pharma

GREENVILLE, SC 29605

See insert for drug facts

Structured Label Content

Uses

• for the temporary relief of minor aches and pains due to

headache
muscular aches
backache
sore throat
flu
the common cold
toothache
premenstrual and menstrual cramps

• for the minor pain from arthritis

• and to reduce fever

Section 34088-5 (34088-5)

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 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 the user

• has liver disease

• is a child with pain of arthritis

Section 51727-6 (51727-6)

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/fever reducer

Directions

do not take more than directed (see overdose warning)
dose product from the single dose cup the product is packaged in
mL=milliliter

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
if you are allergic to aetaminophen or any of the inactive ingredients of this product

Distributed by:

PAI Pharma

Greenville,SC 29605

www.paipharma.com

R05/25

Active Ingredient (Active ingredient)

Acetaminophen 325 mg

Other Information (Other information)

■ Each 10.15 mL contains: sodium 12 mg

■ store at 20° to 25°C (68° to 77°F)

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)

adult's pain gets worse or lasts more than 10 days
child's 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

Principal Display Panel 10.15 Ml Cup (PRINCIPAL DISPLAY PANEL - 10.15 mL Cup)

Delivers 10.15 mL

NDC 0121-2094-11

Acetaminophen

Oral Solution USP

325 mg/10.15 mL

Pain Reliever/Fever Reducer

Alcohol Free/Dye Free/Sugar Free

Grape Flavored

Package Not Child-Resistant

Dist. by: PAI Pharma

GREENVILLE, SC 29605

See insert for drug facts

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• for the temporary relief of minor aches and pains due to headache muscular aches backache sore throat flu the common cold toothache premenstrual and menstrual cramps • for the minor pain from arthritis • and to reduce fever", "34088-5": "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.", "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", "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 the user • has liver disease • is a child with pain of arthritis", "51727-6": "Inactive ingredients anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Pain reliever/fever reducer", "Directions": "do not take more than directed (see overdose warning ) dose product from the single dose cup the product is packaged in mL=milliliter 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 if you are allergic to aetaminophen or any of the inactive ingredients of this product", "Distributed by:": "PAI Pharma Greenville,SC 29605 www.paipharma.com R05/25", "Active ingredient": "Acetaminophen 325 mg", "Other information": "■ Each 10.15 mL contains: sodium 12 mg ■ store at 20° to 25°C (68° to 77°F)", "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": "adult's pain gets worse or lasts more than 10 days child's 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", "PRINCIPAL DISPLAY PANEL - 10.15 mL Cup": "Delivers 10.15 mL NDC 0121-2094-11 Acetaminophen Oral Solution USP 325 mg/10.15 mL Pain Reliever/Fever Reducer Alcohol Free/Dye Free/Sugar Free Grape Flavored Package Not Child-Resistant Dist. by: PAI Pharma GREENVILLE, SC 29605 See insert for drug facts "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:35.967126 · Updated: 2026-03-14T23:11:13.760766