Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel NDC 55154-9449-5 ACETAMINOPHEN ORAL SOLUTION USP 650 mg / 20.3 mL 5 CUPS 650mg/20.3mL bag label
- Principal Display Panel NDC 55154-9449-5 ACETAMINOPHEN ORAL SOLUTION USP 650 mg / 20.3 mL 5 CUPS 650mg/20.3mL bag label
Overview
Uses temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • the common cold • toothache • premenstrual and menstrual cramps temporarily reduces fever
Indications & Usage
Uses temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • the common cold • toothache • premenstrual and menstrual cramps temporarily reduces fever
Dosage & Administration
Directions ▪ do not take more than directed (see overdose warning ) 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 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
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. 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. • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • if you are allergic to acetaminophen or any of the inactive ingredients of this product 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. Stop use and ask a doctor if • symptoms do not improve • new symptoms occur • pain or fever persists or gets worse If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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. 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.
Purpose
Purpose 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. • for more than 10 days for pain unless directed by a doctor • for more than 3 days for fever unless directed by a doctor • if you are allergic to acetaminophen or any of the inactive ingredients of this product
Stop Use & Ask a Doctor
Stop use and ask a doctor if • symptoms do not improve • new symptoms occur • pain or fever persists or gets worse
Keep Out of Reach of Children
Keep out of reach of children.
Storage & Handling
Other information ■ 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 20.3 mL unit dose cups per bag, NDC 55154-9449-5
Questions
Questions or comments? Call 1-800-845-8210. You may also report serious side effects to this phone number.
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