Sound Body Herbal Cough Drops by Big Lots / Bestco LLC Menthol 4.8 mg

Sound Body Herbal Cough Drops by

Drug Labeling and Warnings

Sound Body Herbal Cough Drops by is a Otc medication manufactured, distributed, or labeled by Big Lots, Bestco LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOUND BODY HERBAL COUGH DROPS- menthol lozenge 
Big Lots

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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 signes 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 necessary 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, glycerin, herbal extract blend (Elderflower, Horehound, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), medium chain triglycerides, natural flavors, soybean oil, sucrose, water.

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

SOUND BODY HERBAL COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-043
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	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50594-043-50	50 in 1 BAG; Type 0: Not a Combination Product	04/23/2021	08/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/23/2021	08/01/2023

Labeler - Big Lots (017885351)

Registrant - Bestco LLC (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco LLC		002149136	manufacture(50594-043)

Revised: 10/2023

Document Id: 0816e520-b145-1a64-e063-6394a90acf5f

34390-5

Set id: c0a97ddd-cd5a-8602-e053-2995a90a3b34

Version: 3

Effective Time: 20231019