NDC | 57955-0466-2 |
Set ID | b1030fb4-b142-4618-a8b0-5e5abd526ab2 |
Category | HUMAN OTC DRUG LABEL |
Packager | King Bio Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- HPUS Active Ingredients
- Inactive Ingredients
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Directions
- Initially, depress pump until primed
- Spray one dose directly into mouth
Under 6 Months: Consult a licensed healthcare professional before using
6 months to 2 years: 1 spray every 15 minutes, up to 4 doses, then hourly until relieved
2 years and older: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved
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Purpose
Aethusa cynapium.............restlessness, irritability
Aloe................................gas reief, bloating, colic before & after stool
Carbo vegetabilis..............gas with colic, upset stomach
Chamomilla......................irritability, ooversensitivity
Colocynthis......................abdominal discomfort
Mentha piperita.................infantile colic, accumulation of gas
Pulsatilla...........................stomach cramps, desire to be held
Senna..............................colic, gas, constipation
Silicea..............................belching, colic
Valeriana officinalis.............irritability, bloating, sleeplessness
Zingiber officinale................digestive aid, colic pain, flatulence
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Other Information
- Uses
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BABY COLIC RELIEF
aethusa cynapium, aloe, carbo vegetabilis, chamomilla, colocynthis, mentha piperita, pulsatilla, senna, silicea, valeriana officinalis, zingiber officinale liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0466 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM 10 [hp_X] in 59 mL ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE 10 [hp_X] in 59 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 10 [hp_X] in 59 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 10 [hp_X] in 59 mL CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 10 [hp_X] in 59 mL MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA 10 [hp_X] in 59 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 10 [hp_X] in 59 mL SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF 10 [hp_X] in 59 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 [hp_X] in 59 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 10 [hp_X] in 59 mL GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength CARYA OVATA BARK (UNII: X765CF609L) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR) REBAUDIOSIDE A (UNII: B3FUD0528F) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0466-2 1 in 1 CARTON 03/02/2018 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/02/2018 Labeler - King Bio Inc (617901350) Registrant - King Bio Inc (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc 617901350 manufacture(57955-0466)