EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT- menthol lozenge

EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT by

Drug Labeling and Warnings

EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT by is a Otc medication manufactured, distributed, or labeled by Ricola USA Inc., Ricola Ag . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Cough suppressant

Active Ingredient (in each drop)

Menthol, 8.3 mg

Uses

temporarily relieves:

• cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants

Warnings

Ask doctor before use if you have

• persistent chronic cough such as occurs with smoking, asthma, or emphysema
• cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition

Keep out of reach of children.

Directions

• adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
• children under 6 years: ask a doctor

Other Information

Store in a dry place

Inactive Ingredients

extracts of peppermint and a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, invert sugar (fructose/dextrose), natural flavor, starch syrup, sugar

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63667-503
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.3 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)
INVERT SUGAR (UNII: ED959S6ACY)
PEPPERMINT (UNII: V95R5KMY2B)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	24mm
Flavor	MINT	Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63667-503-19	19 in 1 BAG; Type 0: Not a Combination Product	05/27/2013
2	NDC: 63667-503-26	26 in 1 BAG; Type 0: Not a Combination Product	05/27/2013
3	NDC: 63667-503-04	4 in 1 PACKAGE; Type 0: Not a Combination Product	05/27/2013	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/27/2013

Labeler - Ricola USA Inc. (177265261)

Establishment
Name	Address	ID/FEI	Business Operations
Ricola Ag		485393768	manufacture(63667-503)