Active Ingredient(In Each 5 Ml) Purpose - 118 Ml
Acetaminophen 160 mg............. Pain reliever/fever reducer
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Chula Vista for the product Temperal-ito (NDC 69729-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(in each 5 ml) purpose - 118 ml, otc - purpose, uses, warnings -118 ml, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg............. Pain reliever/fever reducer
Pain Reliever & Fever Reducer
temporarily:
temporarily:
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes takes
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.
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 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 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 if
These could be signs of a serious condition
Stop use and ask a doctor if
These could be signs of a serious condition
Keep out of reach of children.
Keep Out Of Reach Of Children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 |
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.
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.
Call toll free 619-600-5632
Monday through Fnday 9AM - 5PM EST
Call toll free 619-600-5632
Monday through Fnday 9AM - 5PM EST
Acetaminophen 160 mg..............Pain reliever/fever reducer
Pain Reliever & Fever Reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes takes
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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.
| 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
NDC 69729-006-04 Temperal-ito
NDC 69729-006-02
* Please review the disclaimer below.