FDA.reportPublic FDA data

Ludens Kiwi-Strawberry

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2020-07-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:23:33

Label at a glance#

ProductLudens Kiwi-Strawberry
Active ingredientPECTIN
Label structure10 sections

Indications and uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Dosage and administration

adults and children 3 years of age and older:   allow one drop to dissolve slowly in mouth. may be repeated as needed or as directed by a doctor children under 3 years of age: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each drop)

Pectin 2.8 mg

Purpose

OTC - PURPOSE SECTION

Oral demulcent

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

WARNINGS SECTION

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 may be serious.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • sore mouth does not improve in 7 days
  • irritation, pain or redness persists or worsens

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth.
  • may be repeated as needed or as directed by a doctor
  • children under 3 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at 20º-25ºC (68º-77ºF) in a dry place
  • contains FD&C yellow no. 5 (tartrazine) as a color additive

Inactive ingredients

INACTIVE INGREDIENT SECTION

ascorbic acid, citric acid, corn syrup, corn starch, FD&C blue no. 1, FD&C yellow no. 5, flavors, malic acid, soybean oil, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


LUDEN’S
Kiwi-Strawberry
Pectin Lozenge/ Oral Demulcent
20 Moisture Drops

Principle display panel: LUDEN’S Kiwi-Strawberry Pectin Lozenge/ Oral Demulcent 20 Moisture DropsPrinciple display panel: LUDEN’S Kiwi-Strawberry Pectin Lozenge/ Oral Demulcent 20 Moisture Drops

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52183-20552183-205-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PECTIN89NA02M4RXACTIB
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CORN SYRUP9G5L16BK6NIACT
STARCH, CORNO8232NY3SJIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
MALIC ACID817L1N4CKPIACT
SOYBEAN OIL241ATL177AIACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT

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
db3a062d-41f4-40b1-8706-aa1d9694e61dfa8efdf5-6441-43d8-8a32-1c210646b1f22020-07-03WarningsExact identifier
spl id: db3a062d-41f4-40b1-8706-aa1d9694e61d
spl set id: fa8efdf5-6441-43d8-8a32-1c210646b1f2

Reported adverse events (FAERS/openFDA)#

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