ADVANCED HONEY LEMON COUGH DROPS- cough drops lozenge

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
ADVANCED FIRST AID, INC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cough suppressant / Oral Anesthetic Uses: temporarily relieves • cough as may occur with a cold • occasional minor irritation and sore throat
Authorization status:
OTC monograph final
Authorization number:
67060-121-01, 67060-121-74

ADVANCED HONEY LEMON COUGH DROPS- cough drops lozenge

ADVANCED FIRST AID, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient (in each lozenge) - Menthol 8.6mg

Cough suppressant / Oral Anesthetic

Uses: temporarily relieves cough as may occur with a cold occasional minor irritation and sore

throat

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

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

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.

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.

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

ADVANCED HONEY LEMON COUGH DROPS

cough drops lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 70 6 0 -121

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

8 .6

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRO SE (UNII: C151H8 M554)

CO RN SYRUP (UNII: 9 G5L16 BK6 N)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

HO NEY (UNII: Y9 H1V576 FH)

LEMO N O IL (UNII: I9 GRO8 24LL)

Product Characteristics

Color

yello w (BRIGHT YELLOW)

S core

no sco re

S hap e

OVAL

S iz e

23mm

Flavor

MENTHOL

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 70 6 0 -121-74

10 0 in 1 CARTON

0 8 /0 7/20 19

1

NDC:6 70 6 0 -121-0 1

1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 8 /0 7/20 19

Labeler -

ADVANCED FIRST AID, INC. (114477180)

Registrant -

ADVANCED FIRST AID, INC. (114477180)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ULTRA SEAL CORPORATION

0 8 57520 0 4

pa c k(6 70 6 0 -121)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pharmalo z Manufacturing, Inc.

0 6 710 19 9 8

ma nufa c ture (6 70 6 0 -121)

ADVANCED FIRST AID, INC.

Revised: 8/2019

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