Nbe
FDA Label NDC 64762-871

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynamic Pharmaceuticals Inc. for the product Nbe (NDC 64762-871). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

Active IngredientsPurpose
Zincum Aceticum 2XReduces 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.

Otc - When Using

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.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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 (Oral 01)

Principal Display Panel – 30 mL Bottle Carton (Oral 01)

* Please review the disclaimer below.