SF Cherry Cough Drop by DZA Brands LLC / BestCo Inc. Menthol 5.8 mg

SF Cherry Cough Drop by

Drug Labeling and Warnings

SF Cherry Cough Drop by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC, BestCo Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SF CHERRY COUGH DROP- 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 5.8 mg

Active ingredient (in each drop)

Menthol 5.8 mg

Purpose

Cough suppressant/

Oral anesthetic

Uses temporarily relieves

cough as may occur with a cold or inhaled irritants

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. 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 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 reach of children.

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

6 calories per drop

Excess consumption may cause laxative effect

Inactive ingredients: acesulfame potassium, blue no. 1, eucalyptus oil, flavoring, hydrogenated starch hydrolysate, isomalt, red no. 40, sucralose and water. Soybean oil used as processing aid.

SF CHERRY COUGH DROP 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-025
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 (Maroon)	Score	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor	CHERRY (Black Cherry)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-025-25	25 in 1 BAG; Type 0: Not a Combination Product	05/17/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/17/2012	01/01/2020

Labeler - DZA Brands LLC (090322194)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(55316-025)

Revised: 10/2018

Document Id: 79283040-26c7-2221-e053-2a91aa0afccb

34390-5

Set id: 4a22a165-0c5b-4bc9-e054-00144ff88e88

Version: 2

Effective Time: 20181026

 

DZA Brands LLC