MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC)- 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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Meyer Lemon and Honey-Cough Relief Lozenges (Oral Anesthetic)

(In each lozenge)

Organic Menthol 5mg

Antitussive (Cough Suppressant) / Oral Anesthetic

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 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).

- 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.

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

Keep out of reach of children.

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.

Store in a cool, dry place.

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.

- 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.

label

MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC) 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70084-614
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
Inactive Ingredients
Ingredient NameStrength
MEYER LEMON (UNII: ZD6P2CXI88)  
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
BARLEY MALT SYRUP (UNII: 22P8DKP670)  
SUGARCANE (UNII: 81H2R5AOH3)  
HONEY (UNII: Y9H1V576FH)  
ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
Product Characteristics
ColoryellowScorescore with uneven pieces
ShapeROUNDSize23mm
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70084-614-0118 in 1 BOX; Type 0: Not a Combination Product01/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/15/2020
Labeler - Quantum, Inc. (044806305)
Establishment
NameAddressID/FEIBusiness Operations
Primrose Candy Company005086855manufacture(70084-614)

Revised: 1/2023
Document Id: f1ec79eb-d3b9-628e-e053-2a95a90a02ac
Set id: 99847797-99e9-40d4-e053-2995a90a972a
Version: 2
Effective Time: 20230110
 
Quantum, Inc.