SMITH BROS MENTHOL EUCALYPTUS COUGH DROPS- menthol lozenge 
Universal holdings I LLC dba Smith Brothers Company

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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SMITH BROS MENTHOL EUCALYPTUS Cough Drops

SMITH BROS MENTHOL EUCALYPTUS Cough Drops

Active Ingredients (per drop)

Menthol 6.5mg

Purposes

Cough suppressant / Oral anesthetic

Uses

temporarily relieves

  • cough as may occur with a cold or inhaled irritants
  • 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, nausesa, or vomiting, consult a 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 ask a 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 breastfeeding, ask a healthcare professional before use.

Keep this and all drugs out of the reach of children.

Directions

Adults and children 5 years and over

Allow 1 drop to dissolve slowly in mouth; may be repeated every two hours or as directed by a doctor.

Under  5 years old

Consult a doctor.

Other Information

  • 15 calories per drop

Inactive Ingredients

Acacia gum, dextrin, eucalyptus oil, FD&C blue no.1, FD&C blue no.2, FD&C red no. 40, flavors, glucose syrup, sucrose, water.

SMITH BROS MENTHOL EUCALYPTUS Cough Drops 30 Drops (76461-024-30)

Label

SMITH BROS MENTHOL EUCALYPTUS COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76461-024
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6.5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CORN SYRUP (UNII: 9G5L16BK6N)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (Off-White With Blue-Green To Blue Specks) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code S
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76461-024-3030 in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/23/201312/18/2015
Labeler - Universal holdings I LLC dba Smith Brothers Company (028979475)
Establishment
NameAddressID/FEIBusiness Operations
Universal holdings I LLC dba Smith Brothers Company028979475manufacture(76461-024)

Revised: 12/2015
 
Universal holdings I LLC dba Smith Brothers Company