NDC | 54973-3174-1 |
Set ID | 6006937b-b611-4c0b-810c-997b955c0a09 |
Category | HUMAN OTC DRUG LABEL |
Packager | Hyland's |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients Purpose "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Argentum Nitricum 12X HPUS gas, stomach pressure and pain Asafoetida 6X HPUS swollen tummy, gas, restlessness Carbo Vegetabilis 12X HPUS gas especially after feeding, crying, burping Chamomilla 6X HPUS restlessness, fussiness, crying, groaning Cinchona Officinalis 6X HPUS gas discomfort, stomach pressure, colic, constipation Colocynthis 6X HPUS stomach pain and pressure, swollen tummy, disturbed sleep Lycopodium 30X HPUS hard tummy, bloating, burping Nux Moschata 6X HPUS stomach pressure, gas that disturbs sleep Sepia 12X HPUS hard, expanded tummy, stomach pressure and pain - Uses
- Warnings
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Directions
- Measure only with the dosing dropper provided
- Do not use dropper with other products
- On dosing dropper, mL = milliliter
- Fill to prescribed level and dispense liquid slowly into baby's mouth, toward inner cheek
- For best results, clean dropper after each use
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
BABY GAS DROPS
silver nitrate, ferula sumbul root, activated charcoal, chamomile, cinchona officinalis bark, citrullus colocynthis fruit, lycopodium clavatum spore, nutmeg, and sepia officinalis juice liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3174 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 12 [hp_X] in 1 mL FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ) FERULA SUMBUL ROOT 6 [hp_X] in 1 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 12 [hp_X] in 1 mL CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 6 [hp_X] in 1 mL CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6) CITRULLUS COLOCYNTHIS FRUIT 6 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 30 [hp_X] in 1 mL NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG 6 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) GRAPE (UNII: 6X543N684K) SORBIC ACID (UNII: X045WJ989B) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3174-1 1 in 1 CARTON 01/15/2014 1 29.6 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/15/2014 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3174) , pack(54973-3174) Establishment Name Address ID/FEI Business Operations NEXGEN PHARMA, INC. 079424083 manufacture(54973-3174) , pack(54973-3174)