Active Ingredient Menthol 5.8mg

menthol cough drop by

Drug Labeling and Warnings

menthol cough drop by is a Otc medication manufactured, distributed, or labeled by Sound Body, Bestco, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MENTHOL COUGH DROP- cherry menthol lozenge 
Sound Body

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.

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Active Ingredient
Menthol 5.8mg

Active ingredient (in each drop)

Menthol 5.8mg

Purpose

Cough suppressant/Oral anesthetic

Uses temporarily relieves:

• cough as may occur with a cold
• occasional minor irritation and sore throat

Sore throat warning: if sore throat is severe, persists for

more than 2 days, is accompanied or followed by fever,

headache, rash, swelling, nausea, or vomiting, consult a

doctor promptly. If sore mouth symptoms do not improve

in 7 days, see your 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)

When using this product

• do not exceed recommended dosage

Stop use and consult doctor if

• cough persists for more than 7 days, tends to recur, or

is accompanied by fever, rash, or persistent headache.

These could besigns 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 this and all drugs out of the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children

5 years and over

allow 1 drop to dissolve slowly

in mouth. May be repeated

every two hours as necessary

or as directed by a doctor.

children under 5 years

ask a doctor

Other information

• 10 calories per drop

Inactive ingredients: Eucalyptus oil, FD&C red

no. 40, glucose syrup, N&A flavoring, sucrose and water.

Soybean oil and corn starch used as processing aids.

Questions? Or to report an adverse event call

1-800-245-2898. Monday - Friday, 9AM to 4PM EST

MENTHOL COUGH DROP 
cherry menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-032
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.8 mg

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

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor	CHERRY	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50594-032-40	40 in 1 BAG; Type 0: Not a Combination Product	09/24/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/24/2013	02/01/2020

Labeler - Sound Body (017885351)

Registrant - Bestco, Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco, Inc.		002149136	manufacture(50594-032)

Revised: 10/2018

Document Id: 7898cbbf-d811-8529-e053-2991aa0adf67

34390-5

Set id: 49d44219-d520-0768-e054-00144ff88e88

Version: 2

Effective Time: 20181019

 

Sound Body