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Menthol Cough Drop by Valu Merchandisers Co.

Dosage form: lozenge
Ingredients: MENTHOL 5.4mg
Labeler: Valu Merchandisers Co.
NDC Code: 63941-040

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 5.4 mg

Active ingredient (in each drop)

Menthol 5.4 mg

Purpose

Cough Suppressant / Oral Snesthetic

Uses temporarily relieves the following symptoms associated with sore mouth and sore throat:

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. These symptoms may be serious. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

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 headche. These could be signs of a serious condition.

sore throat is severe, of 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: blue flakes (FD&C blue #1, glycerin, gum arabic, potassium sorbate), eucalyptus oil, FD&C Blue no. 1, FD&C red no. 40, glucose syrup, natural flavoring, sucrose and water. Soybean oil and corn starch used as processing aids.

Questions? Or for an adverse event call 1-800-245-2898. Monday through Friday, 9am to 4pm EST

MENTHOL COUGH DROP 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-040
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.4 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
Colorblue (Light blue with flakes) Scorescore with uneven pieces
ShapeOVALSize17mm
FlavorMENTHOLImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:63941-040-3030 LOZENGE in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2013
Labeler - Valu Merchandisers Co. (868703513)
Registrant - BestCo Inc. (002149136)
Establishment
NameAddressID/FEIOperations
BestCo Inc.002149136manufacture(63941-040)

Revised: 07/2013
 
Valu Merchandisers Co.

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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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