Sound Health Throat Relief Pops by Bestco LLC Pectin 12 mg

Drug Details [pdf]

SOUND HEALTH THROAT RELIEF POPS- pectin lozenge
Bestco LLC

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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Pectin 12 mg

Active ingredient (in each pop)

Pectin 12 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 symptoms may be serious.

Stop use and ask doctor if

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

adults and children 3 years and over - allow 1 pop to dissolve slowly in mouth. May be repeated as necessary or as directed by a doctor.

children under 3 years - ask a doctor

Other information

15 calories per pop
not a candy
do not use if bag is torn or open

Inactive ingredients: Citric acid, corn starch, natural flavors, organic liquid raw cane sugar, organic rice syrup, sodium citrate, soybean oil, water.

Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

Sound Health Throat Pops 15ct

SOUND HEALTH THROAT RELIEF POPS
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52642-054
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	12 mg

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple (Purple and Red)	Score	no score
Shape	ROUND	Size	22mm
Flavor	GRAPE (Grape and Strawberry)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52642-054-15	15 in 1 BAG; Type 0: Not a Combination Product	02/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/28/2022	07/05/2022

Labeler - Bestco LLC (002149136)

Registrant - Bestco LLC (002149136)

Name	Address	ID/FEI	Business Operations
Establishment
Bestco LLC		002149136	manufacture(52642-054)

Revised: 7/2022

Document Id: e33deff6-5901-c979-e053-2995a90a58de

Set id: d91738e5-1d31-41d1-e053-2995a90a7aad

Version: 2

Effective Time: 20220707

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