Label: LITTLE REMEDIES SORE THROAT POPS- pectin lozenge
- NDC Code(s): 63029-406-10, 63029-406-20
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated January 1, 2020
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each Pop)
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
- Other information
- Inactive ingredients
- Questions? 1-800-754-8853
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
LITTLE REMEDIES SORE THROAT POPS
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-406 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 5.4 mg Inactive Ingredients Ingredient Name Strength CORN SYRUP (UNII: 9G5L16BK6N) HONEY (UNII: Y9H1V576FH) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color YELLOW (honey color) Score no score Shape ROUND Size 20mm Flavor HONEY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-406-10 10 in 1 CARTON; Type 0: Not a Combination Product 06/01/2015 2 NDC:63029-406-20 20 in 1 BAG; Type 0: Not a Combination Product 06/01/2015 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)