OTC Medication Information: Ludens Red Hot Cinnamon

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.

Drug Facts

A ctive 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
(click image for full-size original)

LUDENS RED HOT CINNAMON
pectin lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-210
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
CORN SYRUP
FD&C BLUE NO. 2
FD&C RED NO. 40
SOYBEAN OIL
SUCROSE
WATER
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 22mm
Flavor CINNAMON Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52183-210-25 25 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 04/01/2017 07/31/2020
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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