Active Ingredient (In Each 5 Ml Teaspoonful)
ACETAMINOPHEN160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Acetaminophen (NDC 55154-9449). 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 teaspoonful), purpose, uses, other, do not use, otc - ask doctor, otc - ask doctor/pharmacist, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACETAMINOPHEN160 mg
Pain reliever/fever reducer
temporarily relieves minor aches and pains due to:
temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
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.
Ask a doctor before use if the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thining drug warfarin.
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.
| age | dose |
|---|---|
adults and children 12 years of age and over | 20.3 mL (650 mg) every 4 to 6 hours |
children 6 to under 12 years of age | 10.15 mL (325 mg) every 4 hours |
children 4 to under 6 years of age | 7.5 mL (240 mg) every 4 hours |
children 2 to under 4 years of age | 5 mL (160 mg) every 4 hours |
children under 2 years of age | consult a doctor |
■ 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
■ a red, cherry flavored solution supplied in the following oral dosage forms:
Overbagged with 5 x unit dose cups of 20.3 mL in each bag, NDC 55154-9449-5
WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
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.
Pharmaceutical Associates, Inc.
Greenville, SC 29605
Distributed By:
Cardinal Health
Dublin, OH 43017
L53336120225
R10/20
* Please review the disclaimer below.