NDC | 54973-3252-1, 54973-3252-2 |
Set ID | 275f18d5-739e-4055-9553-10ae2be836ad |
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. Chamomilla 6X HPUS occasional sleeplessness Eupatorium Perfoliatum 6X HPUS headache, cough, sneezing Euphrasia Officinalis 6X HPUS runny eyes, nose and nighttime coughing Gelsemium Sempervirens 6X HPUS sneezing with stuffy nose and occasional sleeplessness Kali Iodatum 6X HPUS headache, runny eyes & nose and occasional sleeplessness - Uses
- Warnings
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Directions
Children under 6 months of age
Consult a licensed health care professional before using this product.
Children 6 months to 1 year of age
Dissolve 2 tablets on tongue every 4 hours during the night as required.
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
BABY NIGHTTIME TINY COLD
matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3252 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_X] EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 6 [hp_X] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND Size 5mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3252-1 1 in 1 CARTON 12/28/2015 1 125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3252-2 6 in 1 PACKET; Type 0: Not a Combination Product 12/28/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/28/2015 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3252) , pack(54973-3252) Establishment Name Address ID/FEI Business Operations Merical, Inc. 029644978 pack(54973-3252)