Purpose
Pain reliever/fever reducer
The following Structured Product Label (SPL) was submitted to the FDA by American Health Packaging for the product Acetaminophen (NDC 60687-751). 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 purpose, active ingredient(in each 10.15 ml cup), uses, liver warning:, allergy alert:, sore throat warning:, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Pain reliever/fever reducer
Acetaminophen 325 mg
temporarily relieves minor aches and pains due to:
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
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.
| 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 |
Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol and sucrose.
Call 1-800-845-8210. You may also report serious side effects to this phone number.
DO NOT USE IF SEAL IS BROKEN.
Distributed by:
American Health Packaging
Columbus, OH 43217
R03/23
Case NDC 60687-751-56/Cup NDC 60687-751-42
ACETAMINOPHEN
ORAL SOLUTION USP
325 mg/10.15 mL
ALCOHOL FREE
Each 10.15 mL contains:
Acetaminophen 325 mg
USUAL DOSAGE:See attached Drug Facts
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].
For Institutional Use Only.
T0657C110323 R03/23
NDC 60687- 751-42
ACETAMINOPHEN
ORAL SOLUTION USP
Pain Reliever/Fever Reducer
325 mg/10.15 mL
ALCOHOL FREE
Delivers 10.15 mL
Protect from light.
See packaging Drug Facts insert for full
prescribing information and storage.
For Institutional Use Only.
American Health Packaging
Columbus, OH 43217
F0657C110323
* Please review the disclaimer below.