Active Ingredient(In Each 5 Ml) Purpose
Acetaminophen 160 mg............. Pain reliever/fever reducer
Temperal-ito Suspension
FDA Label NDC 69729-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
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, otc - purpose, uses, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain Reliever & Fever Reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- sore throat
- the common cold
- flu
- headache
- toothache
Warnings
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.
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Other
When using this product do not exceed recommened dose (see overdose warning)
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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.
Directions
- 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 |
Other Information
- Each teaspoon (5 mL) contains: sodium 3 mg
- Store between 15°-30°C (59°-86°F)
- Protect from freezing. Protect from light
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.
Questions Or Comments?
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Monday through Fnday 9AM - 5PM EST
Principal Display Panel
NDC 69729-006-04 Temperal-ito
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