Sore Throat

Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2021-02-12
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 22:52:49

Label at a glance#

ProductSore Throat Cherry

Active ingredientPHENOL

Label structure9 sections

Indications and uses

temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

Dosage and administration

apply to affected area use every 2 hours allow to remain in place for at least 15 seconds, then spit out age dose adults and children 12 years and over for each application, spray 5 times children 3 to 11 years should be supervised in use of this product for each application, spray 3 times children under 3 years ask a doctor or dentist

Storage and handling

store at 20º-25ºC (68º-77ºF). Do not refrigerate.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenol 1.4%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic/Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves sore throat pain, sore mouth, pain associated with canker sores, minor mouth irritation

Warnings

WARNINGS SECTION

Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age.

When using this product,

OTC - WHEN USING SECTION

do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

swelling, rash or fever develops
irritation, pain or redness persists or worsens
sore mouth symptoms do not improve in 7 days
difficulty in breathing occurs

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply to affected area
use every 2 hours
allow to remain in place for at least 15 seconds, then spit out

age	dose
adults and children 12 years and over	for each application, spray 5 times
children 3 to 11 years	should be supervised in use of this product for each application, spray 3 times
children under 3 years	ask a doctor or dentist

Other information

STORAGE AND HANDLING SECTION

store at 20º-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, FD&C red #40, glycerin, natural & artificial flavor, purified water, saccharin sodium

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1869-6	2024-08-19	C162847	48780-1	ba0f9c33-14f4-a910-e053-dadaa90a0b85	Drug Facts
68071-1869-6	2023-01-30	C162847	48780-1	ba0f9c33-14f4-a910-e053-dadaa90a0b85	Drug Facts
68071-1869-6	2021-02-12	C162847	48780-1	ba0f9c33-14f4-a910-e053-dadaa90a0b85	Drug Facts
68071-1869-6	2021-01-29	C162847	48780-1	ba0f9c33-14f4-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-991-36	ML - Milliliter	49348-991	050079cd-4148-4ced-8a13-2f1e5869bef5	1	2014-11-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Sore Throat Cherry
Phenol
ALCOHOL
FD&C RED NO. 40
GLYCERIN
WATER
SACCHARIN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-1869	68071-1869-6
49348-991

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
PHENOL	339NCG44TV	ACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
1d5ff3e4-b10c-0cbc-e063-6394a90a9ea1			5a2da8d4-2f7d-d6dc-e053-2a91aa0ad017	2024-07-16	Warnings	Exact identifier spl set id: 5a2da8d4-2f7d-d6dc-e053-2a91aa0ad017

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.