OTC Medication Information: Ludens Kiwi-Strawberry

LUDENS KIWI-STRAWBERRY- pectin lozenge
Prestige Brands Holdings, 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.

Drug Facts

Active ingredient

(in each drop)

Pectin 2.8 mg

Purpose

Oral demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth 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 may be serious.

Stop use and ask a doctor if:

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

Keep out of reach of children .

Directions

  • 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

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

Inactive ingredients

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?

1-866-583-3677 Ludens.com

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 Drops
(click image for full-size original)

LUDENS KIWI-STRAWBERRY
pectin lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-205
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PECTIN (PECTIN) PECTIN 2.8 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
CORN SYRUP
STARCH, CORN
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
MALIC ACID
SOYBEAN OIL
SUCROSE
WATER
Product Characteristics
Color GREEN (pale green) Score no score
Shape OVAL Size 23mm
Flavor STRAWBERRY (Kiwi-Strawberry) Imprint Code LUDENS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52183-205-20 20 LOZENGE in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 07/02/2012 05/31/2021
Labeler — Prestige Brands Holdings, Inc. (159655021)

Revised: 07/2020 Prestige Brands Holdings, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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