Childrens Pain Relief and Fever Reducer Oral Suspension Cherry 160 mg/5mL

ACETAMINOPHEN · SUSPENSION · Puro Pharma Inc.

No Recall HistoryCurrently in Shortage

Plain English

Childrens Pain Relief and Fever Reducer Oral Suspension Cherry is a suspension containing acetaminophen at 160 mg/5mL, taken oral. Manufactured by Puro Pharma Inc..

Key Facts

Brand Name: Childrens Pain Relief and Fever Reducer Oral Suspension Cherry
Generic Name: ACETAMINOPHEN
NDC Code (Product): 83474-001
Manufacturer: Puro Pharma Inc.
Strength: 160 mg/5mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 03/28/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use22,386 reports

fatigue20,435 reports

drug ineffective18,154 reports

pain18,106 reports

nausea17,622 reports

headache16,713 reports

toxicity to various agents15,538 reports

dyspnoea14,576 reports

arthralgia14,309 reports

pyrexia14,270 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. ■ shake well before using ■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age. ■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours ■ do not give for more than 5 days unless directed by a doctor. Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2 - 3 years 5 mL (1 tsp) 36-47 4 - 5 years 7.5 mL (1 1/2 tsp) 48-59 6 - 8 years 10 mL (2 tsp) 60-71 9 - 10 years 12.5. mL (2 1/2 tsp) 72-95 11 years 15 mL (3 tsp) * 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.

Frequently Asked Questions

What is Childrens Pain Relief and Fever Reducer Oral Suspension Cherry used for?

Childrens Pain Relief and Fever Reducer Oral Suspension Cherry contains ACETAMINOPHEN. It is a suspension taken oral. Consult your doctor for specific uses.

Is Childrens Pain Relief and Fever Reducer Oral Suspension Cherry a controlled substance?

Childrens Pain Relief and Fever Reducer Oral Suspension Cherry is not classified as a controlled substance by the DEA.

What is the generic name for Childrens Pain Relief and Fever Reducer Oral Suspension Cherry?

The generic name for Childrens Pain Relief and Fever Reducer Oral Suspension Cherry is ACETAMINOPHEN. There are 12 other brand versions of ACETAMINOPHEN.

What is the NDC code for Childrens Pain Relief and Fever Reducer Oral Suspension Cherry 160 mg/5mL?

The NDC (National Drug Code) for Childrens Pain Relief and Fever Reducer Oral Suspension Cherry 160 mg/5mL is 83474-001, listed by Puro Pharma Inc..

Product NDC

83474-001

Package NDC

83474-001-04

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)