Label: BABY NIGHTTIME TINY COLD- matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet
- NDC Code(s): 54973-3252-1, 54973-3252-2
- Packager: Hyland's
- 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.
Updated July 19, 2017
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- SPL UNCLASSIFIED SECTION
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
Consult a physician if:
- symptoms persist for more than 72 hours or worsen
- symptoms are accompanied by a high fever (over 101°F)
Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.
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.
Children 1 to 3 years of age
Dissolve 3 tablets on tongue every 4 hours during the night as required.
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton
INGREDIENTS AND APPEARANCE
BABY NIGHTTIME TINY COLD
matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet
Product 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)