Dye Free Childrens Acetaminophen 160 mg/5mL

Acetaminophen · SUSPENSION · PAI Holdings, LLC dba PAI Pharma

No Recall HistoryCurrently in Shortage

Plain English

Dye Free Childrens Acetaminophen is a suspension containing acetaminophen at 160 mg/5mL, taken oral. Manufactured by PAI Holdings, LLC dba PAI Pharma.

Key Facts

Brand Name: Dye Free Childrens Acetaminophen
Generic Name: Acetaminophen
NDC Code (Product): 0121-0966
Manufacturer: PAI Holdings, LLC dba PAI Pharma
Strength: 160 mg/5mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 03/09/2022

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 ineffective18,152 reports

pain18,105 reports

nausea17,622 reports

headache16,715 reports

toxicity to various agents15,539 reports

dyspnoea14,573 reports

arthralgia14,307 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 Use as directed per healthcare professional. 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. repeat dose every 4 hours while symptoms last do not give 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

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 a 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 than 3 days new sympt…

Frequently Asked Questions

What is Dye Free Childrens Acetaminophen used for?

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

Is Dye Free Childrens Acetaminophen a controlled substance?

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

What is the generic name for Dye Free Childrens Acetaminophen?

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

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

The NDC (National Drug Code) for Dye Free Childrens Acetaminophen 160 mg/5mL is 0121-0966, listed by PAI Holdings, LLC dba PAI Pharma.

Product NDC

0121-0966

Package NDC

0121-0966-00

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)