Acetaminophen Oral Solution Usp Ud

Acetaminophen Oral Solution Usp Ud
SPL v1
SPL
SPL Set ID 52ae729b-2255-420c-8db8-cabdc2b74796
Route
ORAL
Published
Effective Date 2024-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Polyethylene Glycol 400 Water Saccharin Sodium Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-16
Description

Drug Facts

Purpose

Pain reliever/fever reducer

How Supplied

A red, cherry flavored solution supplied in the following oral dosage cups: NDC 39328-031-05: 5 mL unit dose cup NDC 39328-031-50: Case contains 50 unit dose cups of 5 mL (39328-031-05). NDC 39328-031-99: Case contains 100 unit dose cups of 5 mL (39328-031-05). NDC 39328-032-10: 10.15 mL unit dose cup NDC 39328-032-50: Case contains 50 unit dose cups of 10.15 mL (39328-032-10). NDC 39328-032-99: Case contains 100 unit dose cups of 10.15 mL (39328-032-10). NDC 39328-034-20: 20.3 mL unit dose cup NDC 39328-034-50: Case contains 50 unit dose cups of 20.3 mL (39328-034-20). NDC 39328-034-99: Case contains 100 unit dose cups of 20.3 mL (39328-034-20).

Medication Information

Purpose

Pain reliever/fever reducer

How Supplied
  • A red, cherry flavored solution supplied in the following oral dosage cups:
NDC 39328-031-05: 5 mL unit dose cup
NDC 39328-031-50: Case contains 50 unit dose cups of 5 mL (39328-031-05).
NDC 39328-031-99: Case contains 100 unit dose cups of 5 mL (39328-031-05).
NDC 39328-032-10: 10.15 mL unit dose cup
NDC 39328-032-50: Case contains 50 unit dose cups of 10.15 mL (39328-032-10).
NDC 39328-032-99: Case contains 100 unit dose cups of 10.15 mL (39328-032-10).
NDC 39328-034-20: 20.3 mL unit dose cup
NDC 39328-034-50: Case contains 50 unit dose cups of 20.3 mL (39328-034-20).
NDC 39328-034-99: Case contains 100 unit dose cups of 20.3 mL (39328-034-20).
Description

Drug Facts

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

Drug Facts

Section 50565-1

Keep Out Of Reach Of Children.

Section 50568-5

Ask a doctor or pharmacist before use if you are 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 breastfeeding, ask a health professional before use.

Allergy

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.

Directions
  • Do not take more than directed (see overdose warning)
  • Use the following dosage guidelines when using this product
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 his product
Sore Throat

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.

Liver Warning

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

  • an adult takes more than 6 doses in 24 hours, or greater than 4000 mg of acetaminophen, the maximum daily amount
  • a child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • taken with 3 or more alcoholic drinks every day while using this product
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.

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
  • Do not use if foil on cup is missing or torn
Inactive Ingredients

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

Questions Or Comments?

Call (800) 936-3088. 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
  • redness or swelling is present
Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Principal Display Panel 5 Ml Cup Label

Delivers 5 mL

NDC 39328-031-05

Acetaminophen

Oral Solution USP

160 mg/5 mL

Alcohol Free

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: yyyy/mm/dd

Patrin Pharma

Skokie, IL 60076

Rev 03.0324

Principal Display Panel 20.3 Ml Cup Label

Delivers 20.3 mL

NDC 39328-034-20

Acetaminophen

Oral Solution USP

650 mg/20.3 mL

Alcohol Free

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: yyyy/mm/dd

Patrin Pharma

Skokie, IL 60076

Rev 03.0324

Principal Display Panel 10.15 Ml Cup Label

Delivers 10.15 mL

NDC 39328-032-10

Acetaminophen

Oral Solution USP

325 mg/10.15 mL

Alcohol Free

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: yyyy/mm/dd

Patrin Pharma

Skokie, IL 60076

Rev 03.0324

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)

Drug Facts

Section 50565-1 (50565-1)

Keep Out Of Reach Of Children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are 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 breastfeeding, ask a health professional before use.

Allergy

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.

Purpose

Pain reliever/fever reducer

Directions
  • Do not take more than directed (see overdose warning)
  • Use the following dosage guidelines when using this product
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 his product
Sore Throat (Sore throat)

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.

How Supplied
  • A red, cherry flavored solution supplied in the following oral dosage cups:
NDC 39328-031-05: 5 mL unit dose cup
NDC 39328-031-50: Case contains 50 unit dose cups of 5 mL (39328-031-05).
NDC 39328-031-99: Case contains 100 unit dose cups of 5 mL (39328-031-05).
NDC 39328-032-10: 10.15 mL unit dose cup
NDC 39328-032-50: Case contains 50 unit dose cups of 10.15 mL (39328-032-10).
NDC 39328-032-99: Case contains 100 unit dose cups of 10.15 mL (39328-032-10).
NDC 39328-034-20: 20.3 mL unit dose cup
NDC 39328-034-50: Case contains 50 unit dose cups of 20.3 mL (39328-034-20).
NDC 39328-034-99: Case contains 100 unit dose cups of 20.3 mL (39328-034-20).
Liver Warning (Liver warning)

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

  • an adult takes more than 6 doses in 24 hours, or greater than 4000 mg of acetaminophen, the maximum daily amount
  • a child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • taken with 3 or more alcoholic drinks every day while using this product
Overdose Warning (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.

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
  • Do not use if foil on cup is missing or torn
Inactive Ingredients

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

Questions Or Comments?

Call (800) 936-3088. 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
  • redness or swelling is present
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 160 mg

Principal Display Panel 5 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 5 mL Cup Label)

Delivers 5 mL

NDC 39328-031-05

Acetaminophen

Oral Solution USP

160 mg/5 mL

Alcohol Free

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: yyyy/mm/dd

Patrin Pharma

Skokie, IL 60076

Rev 03.0324

Principal Display Panel 20.3 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label)

Delivers 20.3 mL

NDC 39328-034-20

Acetaminophen

Oral Solution USP

650 mg/20.3 mL

Alcohol Free

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: yyyy/mm/dd

Patrin Pharma

Skokie, IL 60076

Rev 03.0324

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

Delivers 10.15 mL

NDC 39328-032-10

Acetaminophen

Oral Solution USP

325 mg/10.15 mL

Alcohol Free

For Institutional Use Only

See Insert

Lot# xxxxxx

Exp: yyyy/mm/dd

Patrin Pharma

Skokie, IL 60076

Rev 03.0324

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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.104110 · Updated: 2026-03-14T23:02:59.869199