DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC- menthol lozenge

DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC by

Drug Labeling and Warnings

DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC 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, Oral anesthetic

Active Ingredient (in each drop)

Menthol, 8.3 mg

Uses

temporarily relieves:

• cough due to a cold or inhaled irritants
• occasional minor irritation and pain due to sore throat or sore mouth

Warnings

Sore throat warnings:

• 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 may be serious,
• do not use in children under 6 years of age unless directed by a doctor.

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.
• sore mouth does not improve in 7 days
• irritation, pain, or redness persists or worsens

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

extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), glycerin, malic acid, natural cherry concentrate, natural color, natural flavors, starch syrup, sugar

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63667-224
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)
MALIC ACID (UNII: 817L1N4CKP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63667-224-19	19 in 1 BAG; Type 0: Not a Combination Product	04/03/2011
2	NDC: 63667-224-26	26 in 1 BAG; Type 0: Not a Combination Product	04/03/2011
3	NDC: 63667-224-75	175 in 1 BAG; Type 0: Not a Combination Product	04/03/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/03/2011

Labeler - Ricola USA Inc. (177265261)

Establishment
Name	Address	ID/FEI	Business Operations
Ricola Ag		485393768	manufacture(63667-224)