Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Acetaminophen Solution
FDA Label NDC 0121-1047
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Acetaminophen (NDC 0121-1047). 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 active ingredient (in each 5 ml), purposes, uses, do not use, stop use and ask a doctor if, directions, other information, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
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
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
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
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 mL (640 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 mL (320 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 6 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.
Distributed By:
PAI Pharma
Greenville,SC 29605
www.paipharma.com
R05/25
Principal Display Panel - 5 Ml Cup
Delivers 5 mL
NDC 0121-1047-05
Acetaminophen
Oral Solution USP
160 mg/5 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 5 mL Acetaminophen Fn1047 Cup (Apap Fn1047 5ml 1)
* Please review the disclaimer below.
