Otc - Active Ingredient
Active Ingredients Acetaminophen 200 mgCaffeine 4mg Chlorpheniramine Maleate 4 mg
Ganmaoling
FDA Label NDC 63922-600
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kingsway Trading for the product Ganmaoling (NDC 63922-600). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PurposePain reliever/fever reducerPain reliever aidAntihistamine
Indications & Usage
UsesTemporarily relieves the following symptoms associated with common cold, hay fever, or other upper respiratory allergies: ■ Minor aches and pains ■ Headache ■ Sneezing ■ Itchy, watery eyes ■ Runny nose ■ Sore throat ■ Itching of the nose or throat ■ Fever
Warnings
WarningsSore throat warningIf 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.Liver warningThis product contains acetaminophen, Severe liver damage many occur if you take ■ more than 6 packets in 24 hours, which is the maximum daily amount for this product ■with other drugs containing acetaminophen ■3 or more alcoholic drinks daily while using this product.Do not use with any other drug containing acetaminophen (prescription or nonprescription), if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Otc - Ask Doctor
Ask a doctor before use you have• Glaucoma • A breathing problem such as emphysema or chronic bronchitis • Difficulty in urination due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before you use if you ■have liver disease ■are taking sedatives or tranquilizers ■ are taking the blood thinner drug, warfarin
Otc - When Using
When using this product ■ May cause excitability, especially in children ■ May cause drowsiness, if used with alcohol, sedatives, or tranquilizers ■ Use caution when driving a motor vehicle or operating machinery.
Otc - Stop Use
Stop use and consult a doctor ■ If pain or fever persists or worsen ■ If redness or swelling is present ■ If symptoms last for more than 7 days ■ Fever lasts more than 3 days ■ If new symptoms occur such as rash, nausea or vomiting.
Otc - Keep Out Of Reach Of Children
If pregnant or breast-feeding ask a health professional before using.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms. Do not exceed recommended dosage
Dosage & Administration
Directions■ Adults and children 12 years of age and older: Take 1 packet 3 times a day. Do not exceed 6 packets in 24 hours. ■ Children under 12 years of age: Consult a doctor before using.
Other
Other Information
■ Protect form light and excessive heat ■ Keep tightly closed ■ Keep in dry place
■ Protect form light and excessive heat ■ Keep tightly closed ■ Keep in dry place
Inactive Ingredient
Other IngredientsChrysanthemum (flower), Evodia (unripe fruit), Roughhaired Holly (root), Spanish needles, Peppermint oil.
Package Label.Principal Display Panel
Package Label
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