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NDC 63736-0921-18 SUCRETS VAPOR CHERRY 2; 6 mg/1; mg/1 Details

SUCRETS VAPOR CHERRY 2; 6 mg/1; mg/1

SUCRETS VAPOR CHERRY is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Insight Pharmaceuticals LLC. The primary component is DYCLONINE HYDROCHLORIDE; MENTHOL.

Product Information

NDC	63736-0921
Product ID	63736-921_26d04041-0776-4349-8f7f-917ae2cd74c6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SUCRETS VAPOR CHERRY
Proprietary Name Suffix	n/a
Non-Proprietary Name	dyclonine hydrochloride and menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	2; 6
Active Ingredient Units	mg/1; mg/1
Substance Name	DYCLONINE HYDROCHLORIDE; MENTHOL
Labeler Name	Insight Pharmaceuticals LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63736-0921-18 (63736092118)

Pricing Information	N/A
NDC Package Code	63736-921-18
Billing NDC	63736092118
Package	18 LOZENGE in 1 CANISTER (63736-921-18)
Marketing Start Date	2009-07-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 46819c6e-45af-41c9-b3af-3eec21ec38aa Details

SPL UNCLASSIFIED SECTION

Active ingredient (per lozenge)

Dyclonine hydrochloride 2 mg

Menthol 6 mg

Purpose

Oral anesthetic

Cough suppressant

Uses

For temporary relief of occasional:

minor irritation
pain
sore mouth
sore throat

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Stop use and ask a doctor if

sore mouth symptoms do not improve in 7 days
irritation, pain or redness persists or worsens
swelling, rash or fever develops
cough lasts more than 7 days, comes back, or occurs with fever, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

do not use more than directed
adults and children 4 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist and doctor.
children under 4 years of age: ask a dentist and doctor

Other information

store between 15-30°C (59-86°F)
use only if lozenge blister seals are unbroken

Inactive ingredients

cacesulfame potassium, ascorbic acid, citric acid, corn syrup, fd&c red no. 40, liquid sucrose, propylene glycol, sodium ascorbate, tartaric acid, water, wild cherry flavor, zinc gluconate

PRINCIPAL DISPLAY PANEL

SUCRETS®

DYCLONINE / ORAL ANESTHETIC • MENTHOL / COUGH SUPPRESSANT

18 LOZENGES

VAPOR CHERRY

INGREDIENTS AND APPEARANCE

SUCRETS VAPOR CHERRY

dyclonine hydrochloride and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63736-921
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DYCLONINE HYDROCHLORIDE (UNII: ZEC193879Q) (DYCLONINE - UNII:078A24Q30O)	DYCLONINE HYDROCHLORIDE	2 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 mg

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM ASCORBATE (UNII: S033EH8359)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	19mm
Flavor	CHERRY	Imprint Code	S;Vapor;Cherry
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63736-921-18	18 in 1 CANISTER; Type 0: Not a Combination Product	07/28/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	07/28/2009

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 6/2018

Document Id: 26d04041-0776-4349-8f7f-917ae2cd74c6

Set id: 46819c6e-45af-41c9-b3af-3eec21ec38aa

Version: 1

Effective Time: 20180622