WHOLE FOODS 365 HERBAL COUGH DROPS- menthol lozenge 
Whole Foods

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.

----------

Menthol 4.8 mg

Active ingredient (in each drop)

Menthol 4.8 mg

Purpose

Cough Suppressant / Oral Anesthetic

Uses temporarily relieves:

  • cough due to a cold or inhaled irritants
  • occasional minor irritation due to sore throat or sore mouth

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by feer, 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. Do not administer to children under 3 years of age unless directed by a doctor.

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 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 out of reach of children.

Directions

adults and children 6 years and over - allow 2 drops to disslve slowly in mouth, one at a time. May be repeated every two hours as necessary or as directed by a doctor.

children under 6 years - ask a doctor

Other information

  • 17 calories per drop

Inactive ingredients: Caramel color, corn starch, glucose syrup, highly refined soybean oil, herbal extract blend (Elderflower, Horehound, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), medium chain triglycerides, natural flavors, sucrose and water.

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

Whole Foods Herbal 21ct Cough Drops

WHOLE FOODS 365 HERBAL COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-6515
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorbrownScoreno score
ShapeOVALSize17mm
FlavorPEPPERMINT (Peppermint and Herbs) Imprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42681-6515-121 in 1 BAG; Type 0: Not a Combination Product05/07/201911/17/2022
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/07/201911/17/2022
Labeler - Whole Foods (196175616)
Registrant - Bestco LLC (002149136)
Establishment
NameAddressID/FEIBusiness Operations
Bestco LLC002149136manufacture(42681-6515)

Revised: 11/2022
 
Whole Foods