SUGAR FREE MENTHOL COUGH DROPS- menthol lozenge

Sugar Free Menthol cough drops by

Drug Labeling and Warnings

Sugar Free Menthol cough drops by is a Otc medication manufactured, distributed, or labeled by American Sales, Bestco Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each drop)

Menthol 5.8 mg

PURPOSE

Purpose

Cough suppressant / Oral anesthetic

INDICATIONS & USAGE

Uses temporarily relieves:

cough as may occur with a cold

occasional minor irritation and sore throat

WARNINGS

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 DOCTOR

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

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

• 6 calories per drop
• Excess consumption may cause a laxative effect.

INACTIVE INGREDIENT

Inactive ingredients: Acesulfame potassium (non-nutritive sweetener), corn starch, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, hydrogenated starch hydrolysate, isomalt, medium chain triglycerides, natural and artificial flavors, potassium sorbate, soybean oil, sucralose (non-nutrative sweetener) and water.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUGAR FREE MENTHOL COUGH DROPS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-021
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	blue (Light blue with blue flakes)	Score	no score
Shape	OVAL	Size	16mm
Flavor	MENTHOL	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-021-70	70 in 1 BAG; Type 0: Not a Combination Product	06/22/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/22/2016

Labeler - American Sales (809183973)

Registrant - Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco Inc.		002149136	manufacture(41520-021)