Menthol Cough Drops by L & R Distributors, Inc.
Dosage form: lozenge
Ingredients: MENTHOL 5.4mg
Labeler: L & R Distributors, Inc.
NDC Code: 15127-013
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredient (in each drop)
Menthol 5.4 mg
Purpose
Cough suppressant / Oral anesthetic
Uses temporarily relieves:
cough as may occue with a cold
occasional minor irritation and sore throat
Warnings
Sore throat warning: if sore throat is severe, persits for more than 2 days, is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see you dentist or doctor promptly. These symptoms may be serious.
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)
Stop use and consult a doctor if
cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
sore throat is severe, or irritation, pain or redness lasts or worsens
sore mouth does not improve in 7 days
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Directions
adults and children 5 years and over - allow 1 drop to dissolve slowly in mouth. May be repeated every 2 hours as necessary or as directed by a doctor.
children under 5 years - ask a doctor
Inactive ingredients: Corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, medium chain triglycerides, natural flavor, potassium sorbate, soybean oil, sucrose and water.
Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9AM - 4PM EST
Labeler - L & R Distributors, Inc. (012578514) |
Registrant - Bestco Inc. (002149136) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Bestco Inc. | 002149136 | manufacture(15127-013) |
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.