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Ancient Secrets Breathe Again

Dosage form: aerosol, spray
Ingredients: Sodium Chloride 20mg in 100mL
Labeler: LOTUS BRANDS, INC.
NDC Code: 76328-100

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.

ANCIENT
SECRETS®
Breathe
Again™
Hypertonic Seawater
Nasal Spray

Drug Facts

Active ingredient

Sodium Chloride 2.0% (Seawater-derived)

Purpose

Restores Moisture

Uses

for nasal rinsing in adults:

  • Moisturizes and cleanses nasal passages due to pollution, dry air, air conditioning, dust, pollen
  • Nasal drainage
  • Helps dry congestion due to colds and allergies

Warnings

For nasal use only.

When using this product
  • To avoid contamination, do not touch tip of the dispenser to any surface.
  • Do not use the same dispenser on different people.

Stop use and ask a doctor if you experience any discomfort while using this product.

Keep out of the reach of children.

Directions
  • Tilt head to one side and forward.
    Holding can parallel to the nose, insert nozzle into upper nostril.
  • Press valve briefly for release of fine mist.
    Repeat 2-3 times on each nostril as needed.
  • Use 2-4 times daily, or as often as necessary.
  • Use with children ages 6 and older.
  • Wash carefully with clean warm water and dry carefully after each use.

Other Information
  • Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate.
  • Store at room temperature (59-86°F).

Inactive Ingredients

purified water

Questions, Comments, Side Effects?

Call toll free 800-824-6396, Monday – Friday, 9:00 – 5:00, CST

Manufactured by
Gerolymatos International S.A.
Athens, Greece

®©2011, Distributed by Lotus Brands, Inc.,
A majority woman-owned family business
1100 Lotus Drive, Silver Lake, WI 53170, USA

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

ANCIENT
SECRETS®

Breathe
Again™

Hypertonic Seawater
Nasal Spray

  • Sterilized
  • Helps Dry Congestion
    Due to Colds and Allergies
  • Preservative-Free Saline

3.38 fl.oz. (100 mL)

ANCIENT SECRETS   BREATHE AGAIN
sodium chloride aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76328-100
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Chloride (Sodium Cation) Sodium Chloride20 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Packaging
#Item CodePackage Description
1NDC:76328-100-001 CANISTER (CANISTER) in 1 CARTON
1100 mL in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34908/15/2011
Labeler - LOTUS BRANDS, INC. (879022713)
Establishment
NameAddressID/FEIOperations
GEROLYMATOS INTERNATIONAL SA423075886MANUFACTURE

Revised: 08/2011
Document Id: 7c50a663-7866-40c9-a293-7d4a0cc12153
Set id: c6d2bab0-d363-4c09-a71b-ae15db915b37
Version: 1
Effective Time: 20110801
 
LOTUS BRANDS, INC.

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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