Natural Herbal Cough Drops by DZA Brands LLC / BestCo Inc. Menthol 4.8 mg

Natural Herbal Cough Drops by

Drug Labeling and Warnings

Natural Herbal Cough Drops by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC, BestCo Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NATURAL HERBAL COUGH DROPS- menthol lozenge 
DZA Brands 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 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 in mouth one at a time. May be repeated every two hours as necessry or as directed by a doctor.

children under 6 years ask a doctor

Other information

17 calories per drop

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? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

NATURAL HERBAL COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-022
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	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor	MENTHOL (Natural Herbal)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-022-21	21 in 1 BAG; Type 0: Not a Combination Product	06/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/21/2016	12/01/2019

Labeler - DZA Brands LLC (090322194)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(55316-022)

Revised: 10/2018

Document Id: 79278c29-eef9-448c-e053-2a91aa0a4e4a

34390-5

Set id: 4a26944a-36e4-264f-e054-00144ff8d46c

Version: 2

Effective Time: 20181026

 

DZA Brands LLC