Acetaminophen Solution Liquid
FDA Label NDC 39328-031

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Patrin Pharma, Inc. for the product Acetaminophen Solution (NDC 39328-031). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml), purpose, uses, liver warning, allergy, sore throat, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient (in Each 5 Ml)

→ Purpose

→ Uses

→ Liver Warning

→ Allergy

→ Sore Throat

→ Do Not Use

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ How Supplied

→ Principal Display Panel - 5 Ml Cup Label

→ Principal Display Panel - 10.15 Ml Cup Label

→ Principal Display Panel - 20.3 Ml Cup Label

Other

Drug Facts

Patrin Pharma
Skokie, IL 60076
www.patrinpharma.com

Rev 02.0424

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

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

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

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.

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.

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

Otc - Ask Doctor

Ask a doctor before use if you have liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep Out Of Reach Of Children.

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.

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

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.

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).