NDC | 62106-1202-0 |
Set ID | 270efa03-908b-4827-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Seroyal USA |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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ACTIVE INGREDIENT
Active ingredients
Each drop contains:
Asafoetida (Devil's dung) Gum Resin 6X
Carbo vegetabilis (Vegetable charcoal) 6X
Cinchona succirubra (Cinchona) Bark 6X
Kali carbonicum (Potassium carbonate) 6X
Lycopodium clavatum (Clubmoss) Spores 6X
Nux moschata (Nutmeg) Seeds 6X
Nux vomica (Poison nut) Seeds 6X (<2.7 x 10-7 % alkaloids, calculated)
Raphanus sativus var niger (Black radish) Underground Parts 6X - PURPOSE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
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DOSAGE & ADMINISTRATION
Directions
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.Adults and adolescents (12 years and older)
Take 10 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
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INDICATIONS & USAGE
Uses
For the temporary relief of symptoms associated with digestive upset such as:
BloatingIndigestion
Colic
Directions
To be taken ten minutes away from food.
Invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water.
Hold contents for about 20 seconds and swallow.
To promote drop flow, invert bottle and shake before each use.
Dosage frequency may be increased up to six times daily depending on the severity of symptoms.Adults and adolescents (12 years and older)
Take 10 drops three times daily or as recommended by your healthcare practitioner.
Children (under 12 years)
Take under the direction of your healthcare practitioner.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KALIUM CARBONICUM PLEX
asafoetida, carbo vegetabilis, cinchona succirubra, kali carbonicum, lycopodium clavatum, nux moschata, nux vomica, raphanus sativus var niger liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62106-1202 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA 6 [hp_X] in 30 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 6 [hp_X] in 30 mL CINCHONA PUBESCENS BARK (UNII: S96N10R972) (CINCHONA PUBESCENS BARK - UNII:S96N10R972) CINCHONA PUBESCENS BARK 6 [hp_X] in 30 mL NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 6 [hp_X] in 30 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 6 [hp_X] in 30 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 6 [hp_X] in 30 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_X] in 30 mL RAPHANUS SATIVUS (UNII: 86R5J6D01D) (RAPHANUS SATIVUS - UNII:86R5J6D01D) RAPHANUS SATIVUS 6 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62106-1202-0 1 in 1 CARTON 12/16/2015 1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/16/2015 Labeler - Seroyal USA (018361118) Establishment Name Address ID/FEI Business Operations SAN'UP 401010287 manufacture(62106-1202)