Bing Cherry-Cough Antitussif Relief Lozenges

BING CHERRY COUGH ANTITUSSIF RELIEF ANTITUSSIF- menthol lozenge
Quantum 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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Medicinal Ingredients:

Each lozenge contains:

I-Menthol 5.97mg

Organic Slippery Elm Bark Pwder (Ulmus rubra, Stem bark inner) 10mg

Antitussif

Recommended Dose:

Adults and children 6 years and over. Dissolve one lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor.

Cautions & Warnings:

- If sore throat symptoms are severe or persist more than 2 days consult a doctor.

- If cough worsens, persists more than 7 days or is accompanied by high fever consult a doctor.

Non-Medicinal Ingredients:

Organic Brown Rice Syrup, Organic Sugarcane juice, Beet juice concentrate, Natural Cherry Fruit Juice Concentrate, Organic honey.

Keep out of reach of children

Recommended Use

For the temporary relief of coughs and sore throat.

label

BING CHERRY COUGH ANTITUSSIF RELIEF ANTITUSSIF
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70084-612
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg

Ingredient Name	Strength
Inactive Ingredients
BEET JUICE (UNII: IOZ32L9H3O)
CHERRY JUICE (UNII: 4XTQ10247Y)
HONEY (UNII: Y9H1V576FH)
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)
SUGARCANE (UNII: 81H2R5AOH3)
BARLEY MALT SYRUP (UNII: 22P8DKP670)

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	ROUND	Size	23mm
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70084-612-01	18 in 1 BOX; Type 0: Not a Combination Product	12/11/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/11/2019

Labeler - Quantum Inc. (044806305)

Name	Address	ID/FEI	Business Operations
Establishment
Primrose Candy Company		005086855	manufacture(70084-612)