FDA.reportPublic FDA data

COLD AND FLU RELIEF

Manufacturer
PROTEGE' MEDIA LLC
Effective date
2021-01-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:51

Label at a glance#

ProductCOLD AND FLU RELIEF
Active ingredientATROPINE, NAJA NAJA VENOM, MAGNESIUM CHLORIDE, POTASSIUM HYDROXIDE
Label structure8 sections

Dosage and administration

Do not use if tamperproof cover is missing. Press down 2-3 times to prime the pump. Spray once into each nostril Use 2 times per day to relieve discomfort.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                                       Purpose

Contains atropine (Atropinum) 5X HPUS …………………………………....   runny nose relief
Contains cobra venom preparation (Naja naja) 5X HPUS ……….....  pain relief
Contains magnesium chloride (Magnesia muriatica) 5X HPUS…....  cold remedy
Contains potassium hydroxide (Kali causticum) 7X HPUS ………. .... flu remedy
Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Contains 24 doses

Use

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms associated with colds and flu.

Warnings

WARNINGS SECTION

If symptoms persist or worsen, discontinue use, seek medical attention.
• Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
• If pregnant or breastfeeding ask a health professional before use.
• Consult a medical professional if using other medications for known interactions.
• The use of this dispenser by more than one person may spread infection.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not use if tamperproof cover is missing.
  • Press down 2-3 times to prime the pump.
  • Spray once into each nostril
  • Use 2 times per day to relieve discomfort.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aspartic acid, benzalkonium chloride, glycerin, propylene glycol, purified water, thiamine.

Comments, Questions or Complaints?

OTC - QUESTIONS SECTION

Call 888-735-4009 or info@promedxnow.com

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ATROPINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76524-501-182021-07-23C16284748780-1c7ccaba7-278a-fd44-e053-dadaa90aa01ba434e7e2-31f6-4eee-864d-d4ef7c6b675d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76524-501-18COLD AND FLU RELIEF5 mL in 1 BOTTLE, SPRAYSPRAY51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76524-501COLD AND FLU RELIEF (ATROPINE, NAJA NAJA VENOM, MAGNESIUM CHLORIDE, POTASSIUM HYDROXIDE) SPRAY [PROTEGE' MEDIA LLC]1Legacy NDC, 1 package rows20210114_a434e7e2-31f6-4eee-864d-d4ef7c6b675d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76524-50176524-501-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARTIC ACID30KYC7MIAIIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
THIAMINEX66NSO3N35IACT
ATROPINE7C0697DR9IACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIM
POTASSIUM HYDROXIDEWZH3C48M4TACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b8cf40a1-a3e2-3596-e053-2a95a90aa996a434e7e2-31f6-4eee-864d-d4ef7c6b675d2021-01-13WarningsExact identifier
spl id: b8cf40a1-a3e2-3596-e053-2a95a90aa996
spl set id: a434e7e2-31f6-4eee-864d-d4ef7c6b675d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.