ADVANCED HONEY LEMON COUGH DROPS- cough drops lozenge

ADVANCED HONEY LEMON COUGH DROPS by

Drug Labeling and Warnings

ADVANCED HONEY LEMON COUGH DROPS by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, Pharmaloz Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each lozenge) - Menthol 8.6mg

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. These smptoms may be serious.

Ask a doctor before use if you have:  persistent or chronic cough such as ocurs with smoking, asthma, or emphysema

cough accompanied by excessive phlegm (mucus)

Stop use and consult 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 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 baby, ask a health professional before use. 

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

 Adults and children 5 years and older: Allow lozenge to dissolve slowly in mouth; may be repeated every hour as necessary or as directed by a doctor.

Children under 5 years: Consult a doctor.

INACTIVE INGREDIENT

corn syrup, eucalyptus oil, D&C Yellow #10, FD& C Yellow #6, honey, lemon oil, sucrose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED HONEY LEMON COUGH DROPS 
cough drops lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-121
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.6

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

Product Characteristics
Color	yellow (BRIGHT YELLOW)	Score	no score
Shape	OVAL	Size	23mm
Flavor	MENTHOL	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-121-74	100 in 1 CARTON	08/07/2019
1	NDC: 67060-121-01	1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/07/2019

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-121)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	manufacture(67060-121)