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Name:Nbe
Manufacturer:Dynamic Pharmaceuticals Inc.
Category:Over-the-counter (OTC) Marketed Drugs


cold relief oral spray MINT FLAVOR

NBE - zinc gluconate and zinc acetate spray, metered 
Dynamic Pharmaceuticals Inc.

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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cold relief
oral spray
MINT FLAVOR

Drug Facts

Active Ingredients Purpose
Zincum Aceticum 2X Reduces duration and
severity of the common cold
Zincum Gluconicum 1X

Uses

  • Reduces duration of the common cold
  • Reduces severity of cold symptoms:
    • Sneezing
    • Sore Throat
    • Stuffy Nose
    • Coughing
    • Congestion

Warnings

For oral use only, not for use in nasal pathways.

When using this product

  • Avoid contact with eyes. In case of accidental contact with eyes, flush with water and immediately seek professional help.
  • Stop use and ask doctor if
  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Rite Aid® Pharmacy Cold Relief Oral Mist was formulated to shorten the duration of the common cold and may not be effective for flu or allergies.

Stop use and ask a doctor if symptoms persist or if accompanied by fever.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

  • For best results, use at the first sign of a cold and continue to use for an additional 48 hours after symptoms subside.
  • Adults and children 3 years of age and older:
    • Remove protective over-cap.
    • Spray 4 - 5 times into mouth at the onset of symptoms.
    • Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
    • Repeat every three hours until symptoms are gone.
    • To avoid minor stomach upset, do not take on an empty stomach.
    • Do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
  • Children under 3 years of age:
    • Consult a doctor before use.

Inactive Ingredients

Glycerin, Peppermint Flavor, Potassium Sorbate, Purified Water, Sucralose

DISTRIBUTED BY: RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

RITE
AID®
PHARMACY

*Compare to the active ingredients
in Zicam® Oral Mist Cold Remedy

cold relief
oral spray

zincum aceticum, zincum gluconicum

MINT FLAVOR

shortens the duration and
severity of the common cold

use at the first sign
of a cold

non-drowsy

no metallic aftertaste

HOMEOPATHIC

1.0 FL OZ/30mL

Principal Display Panel – 30 mL Bottle Carton

NBE 
zinc gluconate and zinc acetate spray, metered
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64762-871
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC GLUCONATE (ZINC) ZINC GLUCONATE 12.26 mg  in 1 mL
ZINC ACETATE (ZINC) ZINC ACETATE 0.46 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycerin  
Potassium Sorbate  
Water  
Sucralose  
Product Characteristics
Color      Score     
Shape Size
Flavor PEPPERMINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64762-871-30 1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON contains a BOTTLE, PUMP
1 30 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (64762-871-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 09/30/2010

Labeler - Dynamic Pharmaceuticals Inc. (617660712)
Establishment
Name Address ID/FEI Operations
Dynamic Pharmaceuticals Inc. 617660712 MANUFACTURE

Revised: 08/2010 Dynamic Pharmaceuticals Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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