SMITH BROS WARM APPLE PIE WITH CINNAMON FLAVOR BEADS Warming Throat Drops

Dosage form: lozenge
Ingredients: PECTIN 2.0mg
Labeler: Universal holdings I LLC dba Smith Brothers Company
NDC Code: 76461-114

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.

SMITH BROS WARM APPLE PIE WITH CINNAMON FLAVOR BEADS Warming Throat Drops

SMITH BROS WARM APPLE PIE WITH CINNAMON FLAVOR BEADS Warming Throat Drops


Active Ingredients (per drop)

Pectin 2.0mg

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

Capric triglyceride, FD C red no 40, flavors, gelatin, glucose syrup, sorbitol, silicon dioxide, sucrose, water.

SMITH BROS WARM APPLE PIE WITH CINNAMON FLAVOR BEADS Warming Throat Drops 30 Drops (76461-114-30)

SMITH BROS WARM APPLE PIE WITH CINNAMON FLAVOR BEADS WARMING THROAT DROPS 
pectin lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76461-114
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECTIN (PECTIN) PECTIN2.0 mg
Inactive Ingredients
Ingredient NameStrength
TRICAPRIN 
FD&C RED NO. 40 
GELATIN 
CORN SYRUP 
SORBITOL 
SILICON DIOXIDE 
WATER 
Product Characteristics
Coloryellow (Translucent Yellow With Medium Red Spherical Specks) Scoreno score
ShapeOVALSize22mm
FlavorImprint CodeS
Contains    
Packaging
#Item CodePackage Description
1NDC:76461-114-3030 LOZENGE (LOZENGE) in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/23/2013
Labeler - Universal holdings I LLC dba Smith Brothers Company (028979475)
Establishment
NameAddressID/FEIOperations
Universal holdings I LLC dba Smith Brothers Company028979475manufacture(76461-114)

Revised: 05/2013
 
Universal holdings I LLC dba Smith Brothers Company

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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