HONEY LEMON COUGH DROPS- menthol lozenge 
Freds

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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Menthol 7.5 mg

Active ingredient (in each drop)

Menthol 7.5 mg

Purpose

Cough suppressant / Oral anesthetic

Uses temporarily relieves:

cough as may occur with a cold

occasional minor irritation and sore throat

Warnings

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 excessvie phlegm (mucus)

Stop use and ask 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 irritatin, 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 out of reach of children.

Directions

adults and children 5 years and over - dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

children under 5 years - ask a doctor

Other information

10 calories per drop

Inactive ingredients: Beta carotene (color), corn starch, corn syrup, eucalyptus oil, glycerin, honey, medium chain triglycerides, natural and artificial flavors, soybean oil, sucrose and water.

Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

Freds Honey Lemon 40ct cough drops

HONEY LEMON COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-033
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
ColoryellowScoreno score
ShapeOVALSize17mm
FlavorHONEY (Honey and Lemon) Imprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-033-4040 in 1 BAG; Type 0: Not a Combination Product01/10/2018
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/10/201806/30/2022
Labeler - Freds (005866116)
Registrant - Bestco Inc. (002149136)
Establishment
NameAddressID/FEIBusiness Operations
Bestco Inc.002149136manufacture(55315-033)

Revised: 6/2022
 
Freds