Menthol 5.4 mg

Drug Labeling and Warnings

Drug Details [pdf]

MENTHOL COUGH DROP- menthol lozenge 
ShopKo Stores Operating Co. LLC

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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Menthol 5.4 mg

Active ingredient (in each drop)

Menthol 5.4 mg

Purpose

Cough suppressant/

Oral anesthetic

Uses temporarily relieves:

cough as may occur with a cold

occasional minor irritation and sore throat

Warnings

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 a doctor if

cough persists for more than 7 dyas, 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 this and all drugs out of the reachof 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: Blue flakes (FD&C bue no. 1, glycerin, gum arabic, potassium sorbate), eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glucose syrup, natural 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 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-040
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	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor	MENTHOL	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-040-30	30 in 1 BAG; Type 0: Not a Combination Product	08/14/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/14/2013	08/01/2019

Labeler - ShopKo Stores Operating Co. LLC (023252638)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(37012-040)

Revised: 10/2018

Document Id: 7987a988-906d-ce52-e053-2a91aa0a030a

34390-5

Set id: 4a25d331-e808-39f0-e054-00144ff88e88

Version: 2

Effective Time: 20181031