Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied grape flavored suspension supplied in the following oral dosage forms: NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups. NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups.; PRINCIPAL DISPLAY PANEL - 5 mL Cup Label NDC 0121-0941-05 ACETAMINOPHEN ORAL SUSPENSION 160 mg per 5 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label; PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label NDC 0121-1882-11 ACETAMINOPHEN ORAL SUSPENSION 325 mg per 10.15 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label; PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label NDC 0121-2823-21 ACETAMINOPHEN ORAL SUSPENSION 650 mg per 20.3 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
- How Supplied grape flavored suspension supplied in the following oral dosage forms: NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups. NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups.
- PRINCIPAL DISPLAY PANEL - 5 mL Cup Label NDC 0121-0941-05 ACETAMINOPHEN ORAL SUSPENSION 160 mg per 5 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
- PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label NDC 0121-1882-11 ACETAMINOPHEN ORAL SUSPENSION 325 mg per 10.15 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
- PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label NDC 0121-2823-21 ACETAMINOPHEN ORAL SUSPENSION 650 mg per 20.3 mL DYE FREE/GRAPE FLAVOR Ibuprofen Free/Alcohol Free/Aspirin Free Pain Reliever-Fever Reducer SHAKE WELL BEFORE USING Package Not Child-Resistant Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
Overview
Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Indications & Usage
Uses temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Dosage & Administration
Directions Use as directed per healthcare professional. do not take more than directed (see overdose warning ) shake well before using find the right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not take more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by a doctor Under 24 Under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL Over 96 adults and children 12 years and over 20 mL
Warnings & Precautions
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours 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. if you have ever had an allergic reaction to this product or any of its ingredients 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 thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning ) Stop use and ask a doctor if pain gets worse or lasts more than 10 days (for adults) or 5 days (for children) fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. do not give this product to children for the pain of arthritis unless directed by a doctor If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning 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 for children even if you do not notice any signs or symptoms.
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. if you have ever had an allergic reaction to this product or any of its ingredients
When Using
When using this product do not exceed recommended dose (see overdose warning )
Stop Use & Ask a Doctor
Stop use and ask a doctor if pain gets worse or lasts more than 10 days (for adults) or 5 days (for children) fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. do not give this product to children for the pain of arthritis unless directed by a doctor
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)
Questions
Call 1-800-845-8210.
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