TEMPRA Paracetamol 100mg / mL Syrup (Pediatric Drops) 15mL Strawberry
NONRXDRUG-DR-XY46710-15-st
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Paracetamol (TEMPRA) is useful for reducing fever and for the temporary relief of minor aches, pains and discomfort associated with the common colds or flu, inoculations or vaccinations. It is also valuable in reducing pain following tonsillectomy and adenoidectomy.
Dosage/Direction for Use
Tablet: Indicated doses as follows may be given 3 to 4 times daily or as needed but not more than 5 times daily. (See Table 1.)
Forte Tablet: Indicated doses as follows may be given 3 to 4 times daily or as needed but not more than 5 times daily. (See Table 2.)
Syrup: Dosing is based on single doses in the range of 10-15 mg/kg/dose repeated 3 to 4 times a day. Those indicated as follows may be given every 4 hours as needed but more than 5 times daily. (See Table 3.)
Forte Syrup: Dosing is based on single dose in the range of 10-15 mg/kg/dose repeated 3 to 4 times a day or as needed but not more than 5 times daily. (See Table 4.)
Oral Drops: Dosing is based on single dose in the range of 10 mg/kg/dose repeated 3 to 4 times a day. In very young infants, those doses given as follows may be given every 4 hours but should not exceed more than 4 times in 24 hours. (See Table 5.)
Missed Dose: Since acetaminophen (paracetamol) is taken as needed, the patient may not be on a dosing schedule. Take the missed dose as soon as the patient remembers. Skip the missed dose if it is almost time for the next scheduled dose. Do not take extra medicine to make up to the missed dose.
Overdosage
Signs and Symptoms: Overdose of Paracetamol may manifest as follows: Some patients may have no symptoms during the first 24 hours or may manifest with nonspecific abdominal signs and symptoms such as loss of appetite, nausea and vomiting. Pallor, excessive sweating and weakness may also be noted.
In the second phase, usually after 24 hours, the above signs and symptoms may resolve temporarily and may be replaced by right upper abdominal discomfort or pain and a feeling of fullness brought about by liver enlargement. Decreased urine output may also begin to develop. Liver enzymes (transaminases) and prolongation of prothrombin time may also be noted around this time.
Around 3 to 5 days after, abdominal signs and symptoms such as nausea, vomiting, loss of appetite may reappear accompanied by signs of liver failure such as yellowing of the skin or jaundice, decreased blood glucose and bleeding tendencies. In some cases, acute renal failure may also set in as well as disturbances of cardiac rhythm. Abnormalities in sensorium or consciousness, confusion and decreased body temperature have also been reported.
Patient recovers or may progress to acute and fatal liver failure.
Treatment: A doctor or a Poison Control Center should be consulted immediately if a patient has been given more than the recommended dose or if there is any suspicion that this may have been given or ingested. It should be borne in mind that in some cases patients may appear relatively well initially and may even continue their normal activities for a day or two before the onset of liver or kidney failure. Prompt medical attention is of prime importance to prevent liver toxicity. Delay in seeking medical attention may lead to serious liver failure and other problems.
In the second phase, usually after 24 hours, the above signs and symptoms may resolve temporarily and may be replaced by right upper abdominal discomfort or pain and a feeling of fullness brought about by liver enlargement. Decreased urine output may also begin to develop. Liver enzymes (transaminases) and prolongation of prothrombin time may also be noted around this time.
Around 3 to 5 days after, abdominal signs and symptoms such as nausea, vomiting, loss of appetite may reappear accompanied by signs of liver failure such as yellowing of the skin or jaundice, decreased blood glucose and bleeding tendencies. In some cases, acute renal failure may also set in as well as disturbances of cardiac rhythm. Abnormalities in sensorium or consciousness, confusion and decreased body temperature have also been reported.
Patient recovers or may progress to acute and fatal liver failure.
Treatment: A doctor or a Poison Control Center should be consulted immediately if a patient has been given more than the recommended dose or if there is any suspicion that this may have been given or ingested. It should be borne in mind that in some cases patients may appear relatively well initially and may even continue their normal activities for a day or two before the onset of liver or kidney failure. Prompt medical attention is of prime importance to prevent liver toxicity. Delay in seeking medical attention may lead to serious liver failure and other problems.
Administration
May be taken with or without food.
Contraindications
Paracetamol is contraindicated in patients with known hypersensitivity to acetaminophen (paracetamol). Patients with anemia, cardiac, pulmonary, renal and/or liver diseases must consult first with their physician before taking this drug. These patients must also avoid prolonged use of acetaminophen (paracetamol).
Warnings
If fever persists for more than 3 days (72 hours) or if pain continues for more than 5 days, consult the physician.
As with any drug, if the patient is pregnant or nursing a baby, seek the advice of a health professional before using this product.
As with any drug, if the patient is pregnant or nursing a baby, seek the advice of a health professional before using this product.
Special Precautions
Hepatic toxicity may occur in an adult who takes more than 4 grams (which is the maximum daily amount per day in adults) in 24 hours.
Hepatic toxicity in children may occur if given more than 5 doses (which is the maximum amount per day in children) in 24 hours.
For patients with liver or kidney problems, a doctor must first be consulted before giving this drug.
Care should also be taken in giving acetaminophen (paracetamol) to those who are malnourished or in those with eating disorders.
This should not be taken together with another drug that also contains acetaminophen (paracetamol).
A doctor must always be consulted before giving acetaminophen (paracetamol) especially if the patient is taking other medications (rifampicin, warfarin, phenobarbital, etc).
A doctor must also be consulted for patients who are alcoholics or who regularly ingest alcohol in excess before giving this drug.
It is also wise to remember to check the expiration date on the package or label of this product. Do not use after expiry date.
Consult a Doctor: If fever persists more than 3 days (72 hours) or if pain continues for more than 5 days in children and 10 days in adults, consult the doctor.
As with any drug, if the patient is pregnant or nursing a baby, seek the advice of a health professional before using this product.
If rashes or any swelling develops, stop the use of acetaminophen (paracetamol) immediately and consult with the doctor.
Signs and symptoms do not improve or new signs develop.
Hepatic toxicity in children may occur if given more than 5 doses (which is the maximum amount per day in children) in 24 hours.
For patients with liver or kidney problems, a doctor must first be consulted before giving this drug.
Care should also be taken in giving acetaminophen (paracetamol) to those who are malnourished or in those with eating disorders.
This should not be taken together with another drug that also contains acetaminophen (paracetamol).
A doctor must always be consulted before giving acetaminophen (paracetamol) especially if the patient is taking other medications (rifampicin, warfarin, phenobarbital, etc).
A doctor must also be consulted for patients who are alcoholics or who regularly ingest alcohol in excess before giving this drug.
It is also wise to remember to check the expiration date on the package or label of this product. Do not use after expiry date.
Consult a Doctor: If fever persists more than 3 days (72 hours) or if pain continues for more than 5 days in children and 10 days in adults, consult the doctor.
As with any drug, if the patient is pregnant or nursing a baby, seek the advice of a health professional before using this product.
If rashes or any swelling develops, stop the use of acetaminophen (paracetamol) immediately and consult with the doctor.
Signs and symptoms do not improve or new signs develop.
Adverse Reactions
Skin rashes, other allergic reactions.
Drug Interactions
Avoid alcohol while taking Paracetamol as this may increase acetaminophen-induced liver damage.
Anticonvulsant drugs, diflunisal, isoniazid, aspirin, warfarin, cholestyramine, product containing acetaminophen (paracetamol) and drugs that affect liver enzyme should be avoided.
Anticonvulsant drugs, diflunisal, isoniazid, aspirin, warfarin, cholestyramine, product containing acetaminophen (paracetamol) and drugs that affect liver enzyme should be avoided.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
When stored below 30°C and protect from light, Paracetamol (TEMPRA) Tablet & Syrup will remain stable until expiration date indicated on the package.
When stored below 30°C and protect from light, Paracetamol (TEMPRA) Tablet & Syrup will remain stable until expiration date indicated on the package.
Action
Paracetamol is an analgesic-antipyretic drug. It is not a salicylate. It contains no phenacetin or caffeine. It has no effect on prothrombin time. Paracetamol (TEMPRA) is particularly valuable for use in patients who do not tolerate aspirin well because it is less likely to cause gastrointestinal distress.
MedsGo Class
Analgesics (Non-Opioid) & Antipyretics
Features
Brand
Tempra
GTIN
8995201801544
Full Details
Dosage Strength
100mg / ml
Drug Ingredients
- Paracetamol
Drug Packaging
Syrup (Pediatric Drops) 15ml
Generic Name
Paracetamol
Drug Flavor
Strawberry
Dosage Form
Syrup (Pediatric Drops)
Registration Number
DR-XY46710
Drug Classification
Over-The-Counter (OTC)
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