FDA Label for Acetaminophen
View Indications, Usage & Precautions
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Pai Holdings, Llc Dba Pai Pharma. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
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
* Please review the disclaimer below.
