Temperal-ito

Acetaminophen · Suspension · Oral

Over the counter

Active ingredient

Active Ingredient(in each 5 mL) Purpose - 118 mL Acetaminophen 160 mg............. Pain reliever/fever reducer Active Ingredient(In each 5 mL) Purpose - 60 mL Acetaminophen 160 mg..............Pain reliever/fever reducer

Purpose

Pain Reliever & Fever Reducer Purpose Pain Reliever & Fever Reducer

Uses

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

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) Warnings - 60 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. Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blister 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 (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)

Do not use

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. 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

Ask a doctor before use if your child has liver disease. Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product

When using this product do not exceed recommened dose (see overdose warning) When using this product do not exceed recommened dose (see overdose warning)

Stop use and ask a doctor

Stop use and ask a doctor if new sympthoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days These could be signs of a serious condition Stop use and ask a doctor if new sympthoms occur redness or swelling is present pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days These could be signs of a serious condition

Keep out of reach of children

Keep out of reach of children. Keep Out Of Reach Of Children

Directions

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 Directions - 60 ml 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 posible, use weight to dose; otherwise, use age only use enclosed measuring syringe repeat dose ebery 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 *or as directed by doctor

Other information

Other information Each teaspoon (5 mL) contains: sodium 3 mg Store between 15°-30°C (59°-86°F) Protect from freezing. Protect from light Other Information store between 20°-25°C (68°-77°F) protect from freezing protect from light

Inactive ingredients

Inactive ingredients acesulfame potassium, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum. Inactive Ingredients acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.

Label text from the FDA structured product label by OPMX Chula Vista (revised Nov 15, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Temperal-ito NDC products (1)

NDCStrength & formLabelerType
69729-006Acetaminophen 160 mg/5mL
Suspension
OPMX Chula VistaOTC MONOGRAPH DRUG

Frequently asked questions

What is Temperal-ito used for?

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

Who makes Temperal-ito?

Temperal-ito is listed by 1 labeler in the FDA NDC directory, including OPMX Chula Vista.