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
Menthol 8.6 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.

STOP USE

Ask a doctor if you have
■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
■ cough accompanied by excessive phlegm (mucus)

STOP USE

Stop us e and ask a 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 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 us e 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
corn syrup, D&C yellow # 10, eucalyptus oil, FD&C yellow # 6, honey, lemon oil, sucrose

QUESTIONS

Questions? Call 1-800-777-4908

PRINCIPAL DISPLAY PANEL

NDC# 68599-0465-9
McKesson
Cough Drops Assorted
Honey Lemon
250 per Jar
MFR# 27996L

INGREDIENTS AND APPEARANCE

MENTHOL 
cough suppressant lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0465
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	0.86 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
LEMON OIL (UNII: I9GRO824LL)
SUCROSE (UNII: C151H8M554)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HONEY (UNII: Y9H1V576FH)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CORN SYRUP (UNII: 9G5L16BK6N)

Product Characteristics
Color	yellow (Translucent)	Score	score with uneven pieces
Shape	OVAL	Size	23mm
Flavor	HONEY (Lemon)	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0465-9	0.86 g in 1 JAR; Type 0: Not a Combination Product	01/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/30/2020

Labeler - McKesson (023904428)