Active Ingredients
Acetaminophen 100 mg
Chlorpheniramine Maleate 2 mg
999 Cold Remedy
FDA Label NDC 12753-305
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by China Resources Sanjiu Medical & Pharmaceutical Co Ltd for the product 999 Cold Remedy (NDC 12753-305). 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 ingredients, purpose, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before you use if you are, when using this product, stop use and consult a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acetaminophen Pain Reliever/Fever Reducer
Chlorpheniramine Maleate Antihistamine
Use
Uses: Temporarily relieves the following symptoms associated with the common cold, hay fever, or other upper resporatory allergies
Minor aches and pains
Headache
Itchy, watery eyes
Muscular aches
Sneezing
Runny nose
Sore Throat
Itching of the nose or throat
Fever
Warnings
Do not use if
Pain lasts more than 10 days.
Fever lasts more than 3 days
If preganent or breast-feeding, ask a health professional before using.
Ask A Doctor Before Use If You Have
Glaucoma
A breathing problem such as emphysema or chronic bronchitis
Difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before You Use If You Are
Taking sedatives or transquilizers
When Using This Product
May cause excitability, especially in children
May cause drowsiness, if used with alcohol, sedatives, or transquilizers.
Use caution when driving a motor vehicle or operating machinery.
Stop Use And Consult A Doctor
If pain or fever persisits or worsen
If redness or swelling is present
If symptoms last for more than 7 days
If new symptoms occur such as rash, nausea or vomitting.
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 or symptoms.
Directions
Adults and children 12 years of age and older: Take 2 capsules each time, three times a day.
Children under 8 years of age: Consult a doctor before using.
Other Information
Protect from light and excessive heat
Keep tightly closed
Keep in dry place
Other Ingredients
Cafferine
Melicope Pteleiforlia Leaf
Bidens Pilosa Whole
Dendranthema Indicum Flower
Ilex Pedunculosa Whole
Drug Facts
Carton.jpg (Carton)
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