Little Remedies Sore Throat Pops: Package Insert and Label Information

LITTLE REMEDIES SORE THROAT POPS- pectin lozenge
Medtech Products 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 Pop)

Pectin 5.4 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 pop 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°-25°C (68°-77°F) in a dry place

Inactive ingredients

caramel color, corn syrup, honey, natural flavor, sucrose, water

Questions? 1-800-754-8853

Mon.-Fri. 8 am to 8 pm EST

LittleRemedies.com

PRINCIPAL DISPLAY PANEL

Little Remedies
Sore Throat Pops
Pectin / Oral Demulcent
10 Pops

PRINCIPAL DISPLAY PANEL
Little Remedies
Sore Throat Pops
Pectin /Oral Demulcent
10 Pops
(click image for full-size original)

LITTLE REMEDIES SORE THROAT POPS
pectin lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-406
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PECTIN (PECTIN) PECTIN 5.4 mg
Inactive Ingredients
Ingredient Name Strength
CORN SYRUP
HONEY
SUCROSE
WATER
Product Characteristics
Color YELLOW (honey color) Score no score
Shape ROUND Size 20mm
Flavor HONEY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-406-10 10 LOZENGE in 1 CARTON None
2 NDC:63029-406-20 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 06/01/2015
Labeler — Medtech Products Inc. (122715688)

Revised: 01/2020 Medtech Products Inc.

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