Label: INFANTS GAS AND COLIC RELIEF- colocynthis, magnesia phosphorica, chamomilla, dioscorea villosa liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63388-643-02 - Packager: Laboratoire Atlas 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.
Drug Label Information
Updated December 13, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients HPUS*
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Purpose
Colocynthis (Bitter apple) 6X.......................................................................upset stomach, abdominal bloating, colic and nausea
Magnesia phosphorica (Magnesium hydrogen phosphate) 6X...........................abdominal cramps
Chamomilla (German chamomile) 6X............................................................hiccups, nausea, agitation and irritability
Dioscorea villosa (Wild yam) 6X...................................................................intestinal gas, burping and colic-like pain
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Uses
This homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve symptoms associated with colic:
• intestinal gas
• abdominal pain
• bloating & hiccups
• nausea
• burping
• upset stomach
*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
- Warnings
- Directions
- Other information
- Inactive ingredients
- CARTON
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INGREDIENTS AND APPEARANCE
INFANTS GAS AND COLIC RELIEF
colocynthis, magnesia phosphorica, chamomilla, dioscorea villosa liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63388-643 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X] in 25 mL MAGNESIUM PHOSPHATE, DIBASIC (UNII: A1Y870209Z) (MAGNESIUM PHOSPHATE, DIBASIC - UNII:A1Y870209Z) MAGNESIUM PHOSPHATE, DIBASIC 6 [hp_X] in 25 mL CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_X] in 25 mL DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA ROOT 6 [hp_X] in 25 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color Score Shape Size Flavor RASPBERRY, GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63388-643-02 1 in 1 CARTON 02/19/2014 1 25 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/19/2014 Labeler - Laboratoire Atlas Inc (247880834) Registrant - Laboratoire Atlas Inc (247880834)
