Label: COLD-FIX- affinity purified antibodies to human gamma interferon tablet
- NDC Code(s): 71344-002-01, 71344-002-02
- Packager: Seme USA Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Updated December 30, 2020
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- 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
- 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.
- Should be taken once daily for 1 to 3 months around cold and flu season
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
affinity purified antibodies to human gamma interferon tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71344-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INTERFERON-.GAMMA. (UNII: P050J5FWC5) (INTERFERON-.GAMMA. - UNII:P050J5FWC5) INTERFERON-.GAMMA. 12 [hp_C] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score 2 pieces Shape ROUND (circular) Size 9mm Flavor Imprint Code COLDFIX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71344-002-02 2 in 1 PACKET 03/27/2017 1 NDC:71344-002-01 20 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/27/2017 Labeler - Seme USA Inc (080579137) Establishment Name Address ID/FEI Business Operations Santonika Uab 520214047 manufacture(71344-002)