Acetaminophen ACETAMINOPHEN PAI HOLDINGS, LLC DBA PAI PHARMA FDA Approved 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
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Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 10.15 mL) Acetaminophen 325 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid edetate disodium flavor glycerin polyethylene glycol 400 purified water sodium benzoate sodium metabisulfite sorbitol sucralose trisodium citrate dihydrate
Strengths
10.15 ml 325 mg
Quantities
15 ml
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D
Packaging

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 lidding for 10.15 mL Acetaminophen Oral Soln FN1047

Package Descriptions
  • 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 lidding for 10.15 mL Acetaminophen Oral Soln FN1047

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
Warnings 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 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. 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.
Purpose

Purposes Pain reliever/fever reducer

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

Keep Out of Reach of Children

Keep out of reach of children.

Storage & Handling

Other information ■ Each 10.15 mL contains: sodium 12 mg ■ store at 20° to 25°C (68° to 77°F)

Questions

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


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