LUDENS RED HOT CINNAMON- 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.

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Ludens

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 20-25C (68-77F) in a dry place

Inactive ingredients

corn syrup, FD&C blue no. 2, FD&C red no. 40, flavors, soybean oil, sucrose, water

Questions?

1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL

Luden’s

Pectin lozenge/ Oral demulcent
Red Hot Cinnamon
25 Throat Drops

Luden’s
Pectin lozenge/ Oral demulcent
Red Hot Cinnamon
25 Throat Drops

LUDENS RED HOT CINNAMON
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-210
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	2.8 mg

Ingredient Name	Strength
Inactive Ingredients
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	22mm
Flavor	CINNAMON	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-210-25	25 in 1 BAG; Type 0: Not a Combination Product	04/01/2017	07/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	04/01/2017	07/31/2020

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 7/2020

Document Id: fa852297-5b7c-4e87-9bc5-a91cea72116f

Set id: a4852d9d-5f9f-4139-9467-b81b5c3a8f5a

Version: 2

Effective Time: 20200703

Prestige Brands Holdings, Inc.