FDA label 76716018-e47d-4509-b48f-157b0a189821

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
76f03c3d-e848-4c0d-90e2-5584a383ef17
SPL ID
76716018-e47d-4509-b48f-157b0a189821
Version
2
Effective date
2017-03-17
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:48:42

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Warnings: 1. Warnings 1) Patients who consume more than three glasses of alcohol on a regular basis must consult a doctor or pharmacist before taking this drug or other antipyretic-analgesics. Patients like this may suffer from liver damage if this drug is taken. 2) The artificial sweetening agent “Aspartame” in this drug is broken down within the body and metabolized into phenylalanine. Must not be taken by phenylketonuric patients that need to control phenylalanine intake. 2. The following patients must administer with care This drug consists of food yellow no. 4 (tartrazine) therefore patients who are sensitive to this component or allergic to it must administer with care. 3. The following patients must consult a doctor or pharmacist before administering this drug. 1) Patient who has parents or siblings suffering from rashes, contact dermatitis, bronchial asthma, allergic coryza, migraines and food allergies. 2) Patients who have had allergic reactions (e.g. fevers, rashes, arthralgia, asthma, pruritus and etc.) from this drug. 3) Children below 14 years who are infected with or are suspected of chickenpox or influenza 4) Patients with liver, kidney or thyroid disease, diabetes, high blood pressure. Patients that are weak and have a high fever. 5) Patients with cardiac disease or of old age 6) Patients with glaucoma (Eg: pain in the eyes, gloomy eyes), patients with dysuria 7) Pregnant women, women who have potential to become pregnant and lactating women 8) Patients being cured by doctors or dentists 4. Other precautions when administering this drug 1) Follow the given instructions and dosages 2) Do not administer simultaneously with other drugs Antitussive expectorants, other cold drugs, antipyretics & analgesics, antihistaminics and sedatives 3) When administering to children, it must be administered under the supervision of a parent or guardian 4) Avoid administration to infants less than 3 months old. Prevent administration to infants between 3 months and 1 year unless inevitable. 5. Be cautious of the following issues when administering or after administering this drug 1) If patients experience symptoms of rashes, flares, nausea, vomitting, constipation, lack of appetite, dysuria and dizziness, stop taking the drug and consult a doctor or pharmacist. (Contains anti-histaminics for dysuria) 2) Drowsiness may occur during administration, therefore avoid administering while driving or operating machines (Contains anti-histaminics) 3) If administered numerous times and there is no change in symptoms, stop administering the drug and consult a doctor or pharmacist. 4) Do not administer continuously on a long term basis 6. Storage directions 1) Store in places out of the reach of children 2) Keep away from direct sunlight and in cool places with low humidity. 3) Do not store in different containers in order to prevent misuse and preserve quality

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.