Drugplain

Temperal-ito 160 mg/5mL

Acetaminophen · SUSPENSION · OPMX Chula Vista

No Recall HistoryCurrently in Shortage
Plain English

Temperal-ito is a prescription suspension containing acetaminophen at 160 mg/5mL, taken oral. Manufactured by OPMX Chula Vista.

Key Facts

Brand Name
Temperal-ito
Generic Name
Acetaminophen
NDC Code (Product)
69729-006
Manufacturer
OPMX Chula Vista
Strength
160 mg/5mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
HUMAN OTC DRUG
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 use22,386 reports
fatigue20,433 reports
drug ineffective18,154 reports
pain18,105 reports
nausea17,623 reports
headache16,713 reports
toxicity to various agents15,538 reports
dyspnoea14,576 reports
arthralgia14,308 reports
pyrexia14,269 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: sore throat the common cold flu headache toothache

Dosage & Administration

Directions - 118 mL this product does not contain directions or complete warnings for adult use. Shake well before using mL= millilitar find right dose on chart below, if possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last only use enclosed measuring syringe do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor Weight (Ib) Age (yr) Dose (mL) under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 mL 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL

Warnings

Warnings -118 mL Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes takes more than 5 doses in 24 hours. which is the maximum daily amount. with other drugs containing acetaminophen. 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 (prescnption or non-prescription). 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 recommened dose (see overdose warning)

Frequently Asked Questions

What is Temperal-ito used for?

Temperal-ito contains Acetaminophen. It is a suspension taken oral. Consult your doctor for specific uses.

Is Temperal-ito a controlled substance?

Temperal-ito is not classified as a controlled substance by the DEA.

What is the generic name for Temperal-ito?

The generic name for Temperal-ito is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for Temperal-ito 160 mg/5mL?

The NDC (National Drug Code) for Temperal-ito 160 mg/5mL is 69729-006, listed by OPMX Chula Vista.