Menthol 7.6 mg

Drug Labeling and Warnings

Drug Details [pdf]

SF HONEY LEMON 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.

----------

Menthol 7.6 mg

Active ingredient (in each drop)

Menthol 7.6 mg

Purposes

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 accmpanied 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, beta carotene, eucalyptus oil, flavoring, hydrogenated starch hydrolysate, isomalt, sucralose, and water. soybean oil used as processing aid.

SF HONEY LEMON COUGH DROP 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-026
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.6 mg

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

Product Characteristics
Color	yellow	Score	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor	LEMON (Honey and Lemon)	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-026-25	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	11/01/2019

Labeler - DZA Brands LLC (090322194)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(55316-026)

Revised: 10/2018

Document Id: 792819ba-4f7f-fcec-e053-2991aa0a20ee

34390-5

Set id: 4a24dce1-b428-39e7-e054-00144ff8d46c

Version: 2

Effective Time: 20181026

 

DZA Brands LLC