Kiddilets

Kiddilets

paracetamol

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Paracetamol.
Description
Chewable tablet: Each chewable tablet contains: Paracetamol 120 mg.
Syrup: Each 5 mL (one teaspoonful) contains: Paracetamol, USP 120 mg.
Action
Pharmacology: Syrup: Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentration occurring about 30 minutes to 2 hours after ingestion. It is metabolized in the liver and excreted in the urine mainly as glucuronide and sulphate metabolites of paracetamol were reduced after administration of salicylamide. The elimination half-life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentration but increases with increasing concentrations.
Indications/Uses
Chewable tablet: For fever reduction.
For the temporary relief of minor aches and pains such as toothache, headache, backache menstrual cramps, muscular aches, minor arthritis pain, and pain associated with the common cold and flu.
Syrup: Used in the symptomatic relief of pain and fever.
Dosage/Direction for Use
Chewable tablet: This medicine should be taken orally every 4 hours, as needed for pain and/or fever, or, as directed by a doctor (see table).

Click on icon to see table/diagram/image

A child should not exceed 5 doses in each 24-hour period.
An adult should not take more than 4 g in each 24-hour period.
Chew before swallowing.
Do not use continuously for more than 5 days at a time unless directed by a doctor.
Missed Dose: If a dose is missed, give the next dose if still needed for pain and/or fever and the subsequent dose every 4 hours thereafter.
Do not double the dose.
Syrup: 1 to 5 years old: 5 mL (1 teaspoonful) to 10 mL (2 teaspoonfuls).
6 to 12 years old: 10 mL (2 teaspoonfuls) to 20 mL (4 teaspoonfuls).
To be taken 3 to 4 times a day. Or, as prescribed by the physician.
Overdosage
Chewable tablet: Overdosage of Paracetamol usually involves 4 phases with the following signs and symptoms: I. Eating disorder, nausea, vomiting, malaise, and excessive sweating.
II. Right upper abdominal pain or tenderness, liver enlargement which may be characterized by abdominal discomfort of "feeling full", elevated bilirubin and liver enzyme concentrations, prolongation of prothrombin time, and occasionally decreased urine output.
III. Eating disorder, nausea, vomiting, and malaise recur and signs of liver (e.g., jaundice) and possibly kidney failure.
IV. Recovery or progression to fatal complete liver failure.
If more than the recommended dosage has been given, consult a doctor or contact a Poison Control Center right away. Quick medical attention is important for adults as well as for children even if the patient do not notice any signs or symptoms.
Syrup: Overdosage with paracetamol can result in severe liver damage and sometimes acute renal tubular necrosis. Prompt treatment with acetylcysteine or methionine is essential.
Contraindications
Chewable tablet: If the patient is allergic to Paracetamol or to any other ingredient in the product.
Avoid long-term use of Paracetamol in patients with anemia or with heart, lung, kidney, or liver disease.
Syrup: Known hypersensitivity to paracetamol. Long term use in patients with anemia or cardiac pulmonary, renal and/or hepatic disease is also contraindicated.
Warnings
Syrup: If fever persists for more than 3 days or if pain continue for more than 45 days, physician should be consulted.
Special Precautions
Chewable tablet: Liver Warning: This product contains Paracetamol. Severe liver damage may occur if: An adult takes more than 4 g in 24 hours, which is the maximum daily amount; A child takes more than 5 doses in 24 hours, which is the maximum daily amount; Taken with other medicines containing Paracetamol (or Acetaminophen); An adult has 3 or more alcoholic drinks everyday while using this product.
Do not use with any other medicine containing Paracetamol (prescription or nonprescription). If the patient is not sure whether a medicine contains Paracetamol, ask a doctor.
Ask a doctor before use if the patient has liver disease.
Ask a doctor before use if the patient is taking Warfarin, a blood thinning medicine.
When to consult a doctor: Consult a doctor promptly 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 before use if the patient is phenylketonuric. This product contains Phenylalanine as one of the metabolites of aspartame.
If the patient is pregnant or breastfeeding, consult the doctor before use.
Stop use and ask a doctor if: New symptoms occur; Redness or swelling is present; Pain gets worse or lasts more than 5 days; Fever gets worse or lasts more than 3 days.
Syrup: Paracetamol should be given with caution to patients with impaired kidney or liver functions as well as to patients taking other drugs that affect the liver and to patients with alcohol dependence.
Adverse Reactions
Chewable tablet: Paracetamol when taken within the recommended dose and duration of treatment, has low incidence of side effects.
Skin rashes and minor stomach and intestinal disturbances have been reported.
Syrup: When taken in recommended dose, paracetamol is usually free from side effects. Skin reactions, e.g., urticaria have been described rarely. Overdosage with paracetamol can result in severe liver damage and sometimes acute renal tubular necrosis. Prompt treatment with acetylcysteine or methionine is essential.
Drug Interactions
Chewable tablet: Medicines which stimulate the enzymes responsible for the metabolic activation of Paracetamol such as medicines for convulsion (e.g., Phenobarbital) may increase susceptibility to the harmful effects to the liver.
Warfarin, a blood thinning medicine; an increase in the International Normalized Ratio (INR), which may serve as a sign of increased risk for bleeding, may be observed when using Paracetamol and Warfarin at the same time. Paracetamol increases the anticoagulation effect of Warfarin.
Syrup: May interact with alcohol, oral anticoagulants, chloramphenicol, aspirin, phenobarbital, liver enzyme inducer, hepatotoxic agents.
Storage
Chewable tablet: Do not store above 30°C.
Syrup: Store at temperatures not exceeding 30°C. Protect from light. Always keep bottle tightly closed.
MIMS Class
Analgesics (Non-Opioid) & Antipyretics
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.
Presentation/Packing
Chewable tab 120 mg (lemon, orange or strawberry flavor; yellow, orange or pink color; mottled, round, 1/2" diameter, flat bevel-edged, plain on both sides) x 20's, 500's. Syr 120 mg/5 mL x 60 mL.
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