COLD-FIX- human gamma interferon tablet 
Seme USA Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Human Gamma Interferon, C12

Human Gamma Interferon, C30

Human Gamma Interferon, C200

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

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

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

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

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

Lactose monohydrate, Magnesium Stearate, Microcrystalline cellulose

  • 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

Cold-Fix 20 Cold-Fix 40

COLD-FIX 
human gamma interferon tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71344-000
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INTERFERON-.GAMMA. (UNII: P050J5FWC5) (INTERFERON-.GAMMA. - UNII:P050J5FWC5) INTERFERON-.GAMMA.12 [hp_C]  in 1 [hp_C]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (circular) Size9mm
FlavorImprint Code COLDFIX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71344-000-0120 [hp_C] in 1 BLISTER PACK; Type 0: Not a Combination Product03/27/2017
2NDC:71344-000-0240 [hp_C] in 1 BLISTER PACK; Type 0: Not a Combination Product03/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/27/201703/31/2017
Labeler - Seme USA Inc (080579137)
Establishment
NameAddressID/FEIBusiness Operations
UAB Santonika520214047repack(71344-000)

Revised: 3/2017
 
Seme USA Inc