MENTHOL- cough suppressant lozenge

Menthol by

Drug Labeling and Warnings

Menthol by is a Otc medication manufactured, distributed, or labeled by McKesson, Pharmaloz Manufacturing, Inc., Prestige Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each drop)

Menthol 7.6 mg

PURPOSE

Purpose

Antitussive (cough suppressant)/oral anesthetic

INDICATIONS & USAGE

Uses
Temporarily relieves

• cough as may occur with a cold or inhaled irritants
• 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, nausea, or vomiting, consult a 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

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

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

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children.

DOSAGE & ADMINISTRATION

Directions

• do not use more than directed

Adults and children: (12 years and older)

• Allow 1 drop to dissolve slowly in the mouth.
• May be repeated every 2 hours as necessary or as directed by a doctor.

Children under 12 years:
Do not give to children under 12 years of age.

OTHER SAFETY INFORMATION

Other information

• 15 calories per drop
• store at 59º-86ºF (15º-30ºC)
• protect from moisture & heat

INACTIVE INGREDIENT

Inactive ingredients:
cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose

QUESTIONS

Questions? 1-800-777-4908

PRINCIPAL DISPLAY PANEL

NDC: 68599-0464-9

McKesson

Cough Drops

Menthol Eucalyptus

250 per Jar

MFR# 27996M

INGREDIENTS AND APPEARANCE

MENTHOL 
cough suppressant lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0464
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.7 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)

Product Characteristics
Color	white (Translucent)	Score	score with uneven pieces
Shape	OVAL	Size	23mm
Flavor	MENTHOL (Eucalyptus)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0464-9	0.7 g in 1 JAR; Type 0: Not a Combination Product	01/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/29/2020

Labeler - McKesson (023904428)