SMITH BROS BLACK LICORICE Throat Drops

SMITH BROS BLACK LICORICE Throat Drops by

Drug Labeling and Warnings

SMITH BROS BLACK LICORICE Throat Drops by is a Otc medication manufactured, distributed, or labeled by Universal holdings I LLC dba Smith Brothers Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMITH BROS BLACK LICORICE THROAT DROPS- pectin 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 BLACK LICORICE Throat Drops

SMITH BROS BLACK LICORICE Throat Drops


Active Ingredients (per drop)

Pectin 1.7mg

Purpose

Oral Demulcent

Uses

temporarily relieves

  • minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 5 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 a doctor if

  • sore throat is severe, or irritation, pain or redness lasts or worsens.
  • sore mouth does not improve in 7 days.

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

  • Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F) in a dry place

Inactive Ingredients

FD&C blue no.2, FD&C red no.3, FD&C yellow no.6 glucose syrup, licorice, sucrose, water

SMITH BROS BLACK LICORICE Throat Drops 14 Drops (76461-915-14)

Label

SMITH BROS BLACK LICORICE THROAT DROPS 
pectin lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76461-915
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN1.7 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CORN SYRUP (UNII: 9G5L16BK6N)  
LICORICE (UNII: 61ZBX54883)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorgreen (Dark Green Black) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code SB;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76461-915-1414 in 1 BOX; Type 0: Not a Combination Product05/23/201312/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/23/201312/31/2015
Labeler - Universal holdings I LLC dba Smith Brothers Company (028979475)

Revised: 2/2020
 
Universal h

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