Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup MAJOR ® 0904-7278-41 Children's Acetaminophen Oral Suspension 160 mg per 5 mL Pain Reliever • Fever Reducer Ibuprofen Free / Alcohol Free / Aspirin Free SHAKE WELL Delivers 5 mL • See insert For Institutional Use Only MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 F1781C050822 Children's Acetaminophen Oral Suspension - UD Cup
- PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup MAJOR ® 0904-7278-41 Children's Acetaminophen Oral Suspension 160 mg per 5 mL Pain Reliever • Fever Reducer Ibuprofen Free / Alcohol Free / Aspirin Free SHAKE WELL Delivers 5 mL • See insert For Institutional Use Only MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 F1781C050822 Children's Acetaminophen Oral Suspension - UD Cup
Overview
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 your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product, do not exceed the recommended dose (see overdose warning) Stop use and ask a doctor if : • pain gets worse or lasts more than 5 days • 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.
Indications & Usage
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 your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product, do not exceed the recommended dose (see overdose warning) Stop use and ask a doctor if : • pain gets worse or lasts more than 5 days • 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.
Dosage & Administration
Directions this product does not contain directions or complete warnings for adult use do not take more than directed (see overdose warning) shake well before using mL = milliliter 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 give more than 5 times in 24 hours Weight (lb) Age (yr ) Dose (mL) * Under 24 Under 2 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 * or as directed by a doctor
Warnings & Precautions
Warnings Liver warning : This product contains contains acetaminophen. Severe liver damage may occur if your child takes: • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen 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 your child is allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product, do not exceed the recommended dose (see overdose warning) Stop use and ask a doctor if : • pain gets worse or lasts more than 5 days • 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.
Purpose
Uses temporarily: reduces fever relieves minor aches and pain due to: the common cold flu headache sore throat toothache
Keep Out of Reach of Children
Keep out of the 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 children even if you do not notice any sign or symptoms
Storage & Handling
Other information each 5 mL contains : sodium 2 mg Store at 20° to 25°C (68° to 77°F) a red, strawberry flavored suspension supplied in the following oral dosage form: NDC 0904-7278-41: 5 mL unit dose cup, in a tray of ten cups
Questions
Questions or comments? Call 1-800-845-8210.
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