Menthol Cough Drops by L & R Distributors, Inc. / Bestco Inc. Menthol 5.4 mg

Menthol Cough Drops by

Drug Labeling and Warnings

Menthol Cough Drops by is a Otc medication manufactured, distributed, or labeled by L & R Distributors, Inc., Bestco Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MENTHOL COUGH DROPS- menthol lozenge 
L & R Distributors, Inc.

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.

----------

Menthol 5.4 mg

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

MENTHOL COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15127-013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.4 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue (light blue with blue flakes)	Score	no score
Shape	OVAL	Size	16mm
Flavor	MENTHOL	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15127-013-30	30 in 1 BAG; Type 0: Not a Combination Product	05/08/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/08/2013	02/01/2020

Labeler - L & R Distributors, Inc. (012578514)

Registrant - Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco Inc.		002149136	manufacture(15127-013)

Revised: 10/2018

Document Id: 79873a9a-15ac-fea1-e053-2991aa0a340c

34390-5

Set id: 4daec9c2-8db5-57d0-e054-00144ff88e88

Version: 2

Effective Time: 20181031

 

L & R Distributors, Inc.