Active Ingredient

Drug Labeling and Warnings

Drug Details [pdf]

MENTHOL COUGH DROP- honey lemon lozenge 
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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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Active Ingredient

Active Ingredient

Menthol 7.5mg

Purpose

Cough suppressant/Oral anesthetic

Temporarily relieves:

  • cough as may occur with a cold
  • occasional minor irritation and sore throat

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. If sore

mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These

symptoms 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)

When using this product

  • do not exceed recommended dosage

Stop use and consult doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash,or

persistent headache. These could be signs of a serious condition.

  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

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

Keep this and all drugs out of the reach of children. In case of accidental overdose, get

medical help or contact a Poison Control Center right away.

Directions

adults and children 5 years and over

allow 1 drop to dissolve slowly in mouth. May be repeated

every two hours as necessary or as directed by a doctor.

children under 5 years

ask a doctor

Other information

  • 10 calories per drop

Inactive Ingredients: Beta carotene, eucalyptus oil, glucose syrup, honey, N&A flavoring,

sucrose, and water. Soybean oil and cornstarch used as processing aids.

Questions? Or to report an adverse event call 1-800-245-2898

Monday through Friday, 9AM to 4PM EST

Premier Value Honey Lemon 100ct

MENTHOL COUGH DROP 
honey lemon lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68016-033
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScorescore with uneven pieces
ShapeOVALSize17mm
FlavorLEMON (Honey and Lemon) Imprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68016-033-00100 in 1 BAG; Type 0: Not a Combination Product06/30/2015
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/30/201510/01/2019
Labeler - Premier Value (101668460)
Registrant - Bestco, Inc (002149136)
Establishment
NameAddressID/FEIBusiness Operations
Bestco, Inc002149136manufacture(68016-033)

Revised: 10/2018
Document Id: 78997c40-4ef1-468e-e053-2a91aa0a3b7e
Set id: 43cc254b-6630-63dd-e054-00144ff88e88
Version: 2
Effective Time: 20181019
 
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