FDA Label for Premier Value
View Indications, Usage & Precautions
Premier Value Product Label
The following document was submitted to the FDA by the labeler of this product Yunnan Baiyao Group Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Menthol 5.4 mg
Purpose
Purposes cough suppressant, oral anesthetic
Use
temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat
Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.
Otc - Ask Doctor
Ask a doctor before use if you have: ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough accompanied by excessive phlegm (mucus).
Otc - Stop Use
Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
■ children under 5 years: ask a doctor.
Other Information
■ 10 calories per drop ■ contains: SOY.
Inactive Ingredients
Glucose syrup, sucralose, citric acid, eucalyptus oil, FD&C blue 1, FD&C red 40, flavors, potassium citrate, sucrose, soy lecithin, water
Otc - Questions
Or, to report an adverse event, call 800-245-2898.
Monday - Friday, 9 AM to APM EST
Package Label - Principal Display Panel
30 Drops NDC: 61658-885-30
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