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Natural Herbal Cough Drops

Dosage form: lozenge
Ingredients: MENTHOL 4.8mg
Labeler: DZA Brands LLC
NDC Code: 55316-022

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 as may occur with a cold or inhaled irritants

minor 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 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 dissolve slowly in mouth one at a time. May be repeated every two hours as necessry 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, herbal extract blend (Elder Flower, Horehound, Hyssop, Lemon Balm, Linden Flower, Marshmallow Root, Peppermint, Sage, Thyme, Wild Thyme), natural flavors, soybean oil and sucrose.

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

NATURAL HERBAL COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-022
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4.8 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
ColorbrownScorescore with uneven pieces
ShapeOVALSize17mm
FlavorMENTHOL (Natural Herbal) Imprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:55316-022-2121 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/21/2016
Labeler - DZA Brands LLC (090322194)
Registrant - BestCo Inc. (002149136)
Establishment
NameAddressID/FEIOperations
BestCo Inc.002149136manufacture(55316-022)

Revised: 06/2016
 
DZA Brands LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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