Childrens Acetaminophen 160 mg/5mL

Acetaminophen · SUSPENSION · Major Pharmaceuticals

No Recall HistoryCurrently in Shortage

Plain English

Childrens Acetaminophen is a suspension containing acetaminophen at 160 mg/5mL, taken oral. Manufactured by Major Pharmaceuticals.

Key Facts

Brand Name: Childrens Acetaminophen
Generic Name: Acetaminophen
NDC Code (Product): 0904-7278
Manufacturer: Major Pharmaceuticals
Strength: 160 mg/5mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 06/02/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,389 reports

fatigue20,435 reports

drug ineffective18,155 reports

pain18,104 reports

nausea17,624 reports

headache16,715 reports

toxicity to various agents15,539 reports

dyspnoea14,575 reports

arthralgia14,309 reports

pyrexia14,272 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache

Dosage & Administration

Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • 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 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 *or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Warnings

Warnings Liver warning: This product 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 has ever had an allergic reaction to this product or any of its ingredients 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 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 tha…

Frequently Asked Questions

What is Childrens Acetaminophen used for?

Childrens Acetaminophen contains Acetaminophen. It is a suspension taken oral. Consult your doctor for specific uses.

Is Childrens Acetaminophen a controlled substance?

Childrens Acetaminophen is not classified as a controlled substance by the DEA.

What is the generic name for Childrens Acetaminophen?

The generic name for Childrens Acetaminophen is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for Childrens Acetaminophen 160 mg/5mL?

The NDC (National Drug Code) for Childrens Acetaminophen 160 mg/5mL is 0904-7278, listed by Major Pharmaceuticals.

Product NDC

0904-7278

Package NDC

0904-7278-70

Other Acetaminophen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)