COLD-FIX (FOR CHILDREN)- affinity purified antibodies to human gamma interferon tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
INTERFERON-.GAMMA. (UNII: P050J5FWC5) (INTERFERON-.GAMMA. - UNII:P050J5FWC5)
Available from:
Seme USA Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
To reduce severity and duration of cold and flu symptoms including nasal congestion, cough, and fever - Shortens the durations of cold and flu symptoms - Offers temporary relief of cold and flu symptoms including nasal congestion, cough and fever
Authorization status:
unapproved homeopathic
Authorization number:
71344-003-01, 71344-003-02

COLD-FIX (FOR CHILDREN)- affinity purified antibodies to 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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Affinity purified antibodies to human gamma interferon mixture of

Homeopathic dilution, C12

Homeopathic dilution, C30

Homeopathic dilution, 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 your child is under 6 months of age

Stop use and ask a doctor if symptoms persist more than 4 days

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 children from 6 to 36 months of age, it is recommended to

completely dissolve a tablet in a tablespoon of drinking water.

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 (FOR CHILDREN)

affinity purified antibodies to human gamma interferon tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71344-0 0 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

INTERFERO N-.GAMMA. (UNII: P0 50 J5FWC5) (INTERFERON-.GAMMA. - UNII:P0 50 J5FWC5)

INTERFERON-.GAMMA.

12 [hp_C]

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND (circular)

S iz e

9 mm

Flavor

Imprint Code

COLDFIX

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:71344-0 0 3-0 2 2 in 1 PACKET

0 3/27/20 17

1

NDC:71344-0 0 3-0 1 20 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Seme USA Inc

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 3/27/20 17

Labeler -

Seme USA Inc (080579137)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

UAB Santo nika

520 2140 47

re pa c k(71344-0 0 3)

Revised: 4/2017

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