NBE- zinc gluconate and zinc acetate spray, metered

NBE by

Drug Labeling and Warnings

NBE by is a Otc medication manufactured, distributed, or labeled by Dynamic Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC - UNII:J41CSQ7QDS)	ZINC GLUCONATE	12.26 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS)	ZINC ACETATE	0.46 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Water (UNII: 059QF0KO0R)
Sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64762-871-30	1 in 1 CARTON
1		30 mL in 1 BOTTLE, PUMP

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	Business Operations
Dynamic Pharmaceuticals Inc.		617660712	MANUFACTURE