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)

SMITH BROS BLACK LICORICE THROAT DROPS 
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76461-915
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	1.7 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green (Dark Green Black)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	SB;1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76461-915-14	14 in 1 BOX; Type 0: Not a Combination Product	05/23/2013	12/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/23/2013	12/31/2015

Labeler - Universal holdings I LLC dba Smith Brothers Company (028979475)

Revised: 2/2020

Document Id: 9dac0881-580c-12ce-e053-2995a90a9311

34390-5

Set id: 5f5fd1d1-21e5-4e65-9982-234c6b1808be

Version: 3

Effective Time: 20200203

 

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