Menthol 4.8 mg

Drug Labeling and Warnings

Drug Details [pdf]

HERBAL COUGH DROPS- menthol lozenge 
Topco Associates

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 4.8 mg

Active ingredient (in each drop)

Menthol 4.8 mg

Purpose

Cough suppressant / Oral anesthetic

Uses temporarily relieves:

cough as may occur with a cold or inhaled irritants

minor 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)

Stop use and ask 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 6 years and over - allow 2 drops to dissolve slowly on mouth, one at a time. May be repeated every 2 hours as necessary or as directed by a doctor.

children under 6 years - ask a doctor

Inactive ingredients: Caramel (color), corn starch, glucose syrup, herbal extract blend (Elder Flower, Horehound, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), natural flavors, soybean oil, and sucrose

Questions? Call 1-888-423-0139

HERBAL COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-826
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.8 mg

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

Product Characteristics
Color	brown	Score	no score
Shape	OVAL	Size	17mm
Flavor	PEPPERMINT (herbal blend and peppermint)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-826-50	50 in 1 BAG; Type 0: Not a Combination Product	05/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/25/2016	08/01/2019

Labeler - Topco Associates (006935977)

Registrant - Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco Inc.		002149136	manufacture(36800-826)

Revised: 10/2018

Document Id: 7987a988-9081-ce52-e053-2a91aa0a030a

34390-5

Set id: 3682da84-409e-1090-e054-00144ff88e88

Version: 2

Effective Time: 20181031