Cold-Fix

Manufacturer
Seme USA Inc | Santonika Uab
Effective date
2020-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:58:32

Label at a glance#

ProductCold-Fix
Active ingredientINTERFERON-.GAMMA.
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Affinity purified antibodies to human gamma interferon mixture of

Homeopathic dilution, C12

Homeopathic dilution, C30

Homeopathic dilution, C200

OTC - PURPOSE SECTION

To reduce severity and duration of cold and flu symptoms including nasal congestion, cough, and fever

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE SECTION

  • Shortens the durations of cold and flu symptoms
  • Offers temporary relief of cold and flu symptoms including nasal congestion, cough and fever

WARNINGS SECTION

Warnings

  • Keep out reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Ask a doctor or pharmacist before use if you are pregnant or breastfeeding.
  • Stop use and ask a doctor if symptoms persist more than 4 days
  • Children under 18 years or age should consider Cold-Fix for Children

DOSAGE & ADMINISTRATION SECTION

For Treatment

  • On day 1 of treatment: within the first 2 hours - take a tablet every 30 minutes ( a total of 5 tablets).
  • Next 3 doses should be taken at equal intervals (a total of 8 administrations in the first day)
  • Should be taken 3 times daily approximately every 8 hours at equal intervals over days 2 to 7. The overall duration of treatment is 5 to 7 days.
  • The tablet should be held in the mouth until completely dissolved. Do not take with a meal. No other restrictions apply.

For prophylaxis

  • Should be taken once daily for 1 to 3 months around cold and flu season

INACTIVE INGREDIENT SECTION

Lactose monohydrate, Magnesium Stearate, Microcrystalline cellulose

OTHER SAFETY INFORMATION

  • Cold-Fix contains lactose monohydrate. Individuals who are lactose-intolerant should take precaution when taking this product.
  • Store in original package below 30°C or 86°F.
  • Do not use if blister pack is torn or broken

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold-Fix 20Cold-Fix 20Cold-Fix 40Cold-Fix 40

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71344-002-022025-11-18C16284748780-1d6a99b3a-01f6-a426-e053-dadaa90af4c24c09516f-28cc-20d4-e054-00144ff8d46c
71344-002-022022-01-28C16284748780-1d6a99b3a-01f6-a426-e053-dadaa90af4c24c09516f-28cc-20d4-e054-00144ff8d46c

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71344-002COLD-FIX (AFFINITY PURIFIED ANTIBODIES TO HUMAN GAMMA INTERFERON) TABLET [SEME USA INC]4Legacy NDC20201231_4c09516f-28cc-20d4-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71344-00271344-002-01, 71344-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
43de3a63-1d7f-adf8-e063-6394a90a51ca4c09516f-28cc-20d4-e054-00144ff8d46c2025-11-18WarningsExact identifier
spl set id: 4c09516f-28cc-20d4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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