PREMIER VALUE- cough drops cherry lozenge 
Pharmacy Value Alliance 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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PV-MGC-YNBY Cough Drops Cherry 30

Active Ingredient(s)

Menthol 5.8 mg

Purpose

Purposes cough suppressant, oral anesthetic

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.

Ask a doctor before use if you have: ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens.

Keep out of reach of children.

Directions

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.

■ children under 5 years: ask a doctor.

Other information

■ 10 calories per drop ■ contains: SOY.

Inactive ingredients

Glucose syrup, eucalyptus oil, FD&C blue 2, FD&C red 40, flavors, sucrose, sucralose, soy lechitin, water

Or, to report an adverse event, call 800-245-2898.
Monday - Friday, 9 AM to APM EST

Package Label - Principal Display Panel

PV label

30 Drops NDC: 68016-883-30

PREMIER VALUE 
cough drops cherry lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-883
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CORN SYRUP (UNII: 9G5L16BK6N)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScorescore with uneven pieces
ShapeOVALSize21mm
FlavorMENTHOLImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-883-3030 in 1 BAG; Type 0: Not a Combination Product07/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2023
Labeler - Pharmacy Value Alliance LLC (101668460)
Registrant - Medical Group Care LLC (085137089)

Revised: 7/2023
Document Id: 018f476d-eb8d-6bcf-e063-6394a90a8ec4
Set id: 018f4790-8785-94f4-e063-6394a90a1916
Version: 1
Effective Time: 20230731
 
Pharmacy Value Alliance LLC