MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC)- menthol lozenge

Meyer Lemon and Honey-Cough Relief Lozenges (Oral Anesthetic) by

Drug Labeling and Warnings

Meyer Lemon and Honey-Cough Relief Lozenges (Oral Anesthetic) by is a Otc medication manufactured, distributed, or labeled by Quantum, Inc., Primrose Candy Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

(In each lozenge)

Organic Menthol 5mg

PURPOSE

Antitussive (Cough Suppressant) / Oral Anesthetic

WARNINGS

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 5 years of age unless directed by a physician.

ASK DOCTOR/PHARMACIST

Ask a doctor before use if you have:

- persistent or chronic cough as occurs with smoking, asthma, or emphysema.

- cough that occurs with excessive phlegm (mucus).

STOP USE

- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

- sore mouth symptoms do not improve in 7 days.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. Children under 5years of age: ask a doctor.

OTHER SAFETY INFORMATION

Store in a cool, dry place.

INACTIVE INGREDIENT

Organic Brown Rice Syrup, Organic Cane Syrup, Organic Honey, Natural Meyer Lemon Flavor and Other Natural Flavors, Organic Slippery Elm Bark Powder, and Organic Tumeric.

INDICATIONS & USAGE

- cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritation,

- occasional minor irritation, pain, sore mouth, and sore throat.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC) 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70084-614
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)
MEYER LEMON (UNII: ZD6P2CXI88)
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)
BARLEY MALT SYRUP (UNII: 22P8DKP670)
SUGARCANE (UNII: 81H2R5AOH3)
HONEY (UNII: Y9H1V576FH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70084-614-01	18 in 1 BOX; Type 0: Not a Combination Product	01/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/15/2020

Labeler - Quantum, Inc. (044806305)

Establishment
Name	Address	ID/FEI	Business Operations
Primrose Candy Company		005086855	manufacture(70084-614)