FDA.reportPublic FDA data

Sore throat

Manufacturer
TARGET Corporation
Effective date
2022-11-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:47:35

Label at a glance#

ProductSore throat cherry
Active ingredientPHENOL
Label structure10 sections

Indications and uses

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

Dosage and administration

adults and children 6 years of age and older apply to affected area (one spray) allow to remain in place for at least 15 seconds, then spit out use every 2 hours as directed by a doctor or dentist children under 12 years of age should be supervised in the use of this product children under 6 years of age,consult a doctor or dentist

Storage and handling

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

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 accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

When using this product,

OTC - WHEN USING SECTION

do not exceed recommended dose.

Stop use and ask a dentist or doctor if

OTC - STOP USE SECTION

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

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

  • adults and children 6 years of age and older
    • apply to affected area (one spray)
    • allow to remain in place for at least 15 seconds, then spit out
    • use every 2 hours as directed by a doctor or dentist
  • children under 12 years of age should be supervised in the use of this product
  • children under 6 years of age,consult a doctor or dentist

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-910-6874

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredient in Chloraseptic®*

Sore Throat Spray

Phenol 1.4%

Oral anesthetic / analgestic

relieves sore throat

sugar free

alcohol 0.10%

aspirin free

Cherry flavor

FL OZ (mL)

*This product is not manufactured or distributed by Prestige Brands,Inc., distributor of Chloraseptic®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING.

Distributed by Target Corporation

Minneapolis, MN 55403

Product of U.S.A.

©2016 Target Brands, Inc.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Up & Up Sore Throat Spray
Up & Up Sore Throat Spray

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-376SORE THROAT CHERRY (PHENOL) SPRAY [TARGET CORPORATION]4Legacy NDC20221118_2c5e80da-271f-4381-a96f-9ece86b0e042.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-37611673-376-06

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
NameUNIIKind
PHENOL339NCG44TVACTIB
ALCOHOL3K9958V90MIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ae748513-77eb-4b67-8ed2-0545d779764c2c5e80da-271f-4381-a96f-9ece86b0e0422022-11-17WarningsExact identifier
spl id: ae748513-77eb-4b67-8ed2-0545d779764c
spl set id: 2c5e80da-271f-4381-a96f-9ece86b0e042

Reported adverse events (FAERS/openFDA)#

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