![BABY TINY COLD DAY AND NIGHT VALUE PACK (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM IODIDE, AND MATRICARIA RECUTITA) KIT [HYLAND'S]](https://medic.hrt.org//dailymed/images/be7cff09-ecff-48bd-96d4-dc7d47db7656/BCND_VLPK.jpg)
| NDC | 54973-3158-1, 54973-3252-1, 54973-3307-1 |
| Set ID | be7cff09-ecff-48bd-96d4-dc7d47db7656 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Hyland's |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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DAYTIME
Drug Facts
Active ingredients Purpose "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopæia of the United States. Eupatorium Perfoliatum 6X HPUS headache, cough, sneezing Euphrasia Officinalis 6X HPUS runny eyes & nose Gelsemium Sempervirens 6X HPUS sneezing with stuffy nose Kali Iodatum 6X HPUS headache, runny eyes & nose Uses
■ Temporarily relieves symptoms of common cold in children, including: ■ runny nose or eyes ■ nasal congestion
■ headache ■ sneezing ■ cough
Warnings
Consult a physician if: ■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection develops.
■ symptoms are accompanied by a high fever (over 101°F). ■ cough tends to recur or is accompanied by a high fever,
rash or persistent headache.
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 15 minutes for 4 doses, then hourly until relieved.
Children 1 to 3 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.
Hyland's Baby Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.
- Drug Facts (continued)
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NIGHTTIME
Drug Facts
Active ingredients Purpose "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopæia 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
■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion ■ headache ■ sneezing ■ occasional sleeplessness
Warnings
Consult a physician if: ■ symptoms persist for more than 72 hours or worsen ■ inflammation, fever or infection develops.
■ symptoms are accompanied by a high fever (over 101°F) ■ cough tends to recur or is accompanied by a high fever, rash or persistent headache.
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Drug Facts (continued)
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.
Children 1 to 3 years of age: dissolve 3 tablets on tongue every 4 hours during the night as required.
Hyland's Baby Nighttime Tiny Cold Tablets are very soft and will dissolve almost instantly in the mouth.
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - Kit Carton
VALUE PACK
HOMEOPATHIC
NDC 54973-3307-1
6+
MONTHS
NEW
LOOK
BABY
SINCE 1903
Hyland's
Tiny Cold Tablets*
DAYTIME
Relieves nasal
congestion, runny nose,
sneezing and cough
NIGHTTIME
Relieves nasal congestion,
runny nose, sneezing, cough
and occasional sleeplessness
NO ARTIFICIAL FLAVORS, DYES or PARABENS
NATURAL
RELIEF
TWO - 125 Quick-Dissolving Tablet Bottles (1 Day, 1 Night)
TOTAL 250 Quick-Dissolving Tablets
*SEE NOTE ON SIDE
PANEL BELOW DRUG FACTS
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INGREDIENTS AND APPEARANCE
BABY TINY COLD DAY AND NIGHT VALUE PACK
eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, potassium iodide, and matricaria recutita kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3307 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3307-1 1 in 1 CARTON 01/11/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 125 Part 2 1 BOTTLE, PLASTIC 125 Part 1 of 2 TINY COLD
eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet, solubleProduct Information Item Code (Source) NDC:54973-3158 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) ACACIA (UNII: 5C5403N26O) 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:54973-3158-1 1 in 1 CARTON 1 125 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 12/28/2015 Part 2 of 2 BABY NIGHTTIME TINY COLD
matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tabletProduct Information 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 1 125 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 12/28/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/11/2017 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3307) , pack(54973-3307) , label(54973-3307)