Sound Health SF Menthol Cough Drops by Bestco LLC Menthol 5.8mg

Sound Health SF Menthol Cough Drops by

Drug Labeling and Warnings

Sound Health SF Menthol Cough Drops by is a Otc medication manufactured, distributed, or labeled by Bestco LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOUND HEALTH SF MENTHOL COUGH DROPS- menthol lozenge 
Bestco 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 5.8mg

Active ingredient (in each drop)

Menthol 5.8 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 (mucuc)

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 5 years and over - dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

children under 5 years - ask a doctor

Other information

• 6 calories per drop
• Excess consumption may cause a laxative effect.
• donot use if bag is torn or open

Inactive ingredients: Acesulfame potassium, corn starch, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, isomalt, maltitol syrup, medium chain triglycerides, natural and artificial flavors, potassium sorbate, soybean oil, sucralose and water.

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

SOUND HEALTH SF MENTHOL COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52642-053
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)	Â

Product Characteristics
Color	blue (Light Blue with Blue Flakes)	Score	no score
Shape	OVAL	Size	17mm
Flavor	MENTHOL	Imprint Code	B
Contains	   Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52642-053-40	140 in 1 BAG; Type 0: Not a Combination Product	02/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/28/2022	03/01/2022

Labeler - Bestco LLC (002149136)

Registrant - Bestco LLC (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco LLC		002149136	manufacture(52642-053)

Revised: 7/2022

Document Id: e33de81d-7803-709c-e053-2995a90ae4bb

34390-5

Set id: d916a3d4-6a6e-556f-e053-2a95a90aee54

Version: 2

Effective Time: 20220707

Â