| NDC | 54973-3179-1, 54973-3179-2, 54973-3179-4 |
| Set ID | ef39fe3d-a42d-4baa-9199-91f664feb432 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Hyland's |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- PURPOSE
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Drug Facts
Active ingredients Purpose Bryonia 6X HPUS stubborn mucus in throat, cough with yellowish mucus Euphrasia Officinalis 6X HPUS cough with mucus in chest Hepar Sulph Calc 12X HPUS cough up mucus, mucus rattle with cough, stubborn mucus in chest Natrum Muriaticum 30X HPUS accumulation of mucus in throat, cough up mucus Phosphorus 30X HPUS cough with expectoration of yellow mucus, chest congestion Pulsatilla 6X HPUS accumulation of mucus, discharge of thick yellowish mucus, loose cough Rumex Crispus 6X HPUS runny nose, sneezing Silicea 12X HPUS nasal congestion "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Uses
■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose
■ cough with expectoration of thick, discolored mucus
■ runny nose ■ sneezing ■ nasal or chest congestion
Warnings
Consult a physician if:
■ symptoms persist for more than 7 days 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
■ Measure only with the dosing cup provided
■ Do not use dosing cup with other products
■ On dosing cup, mL = milliliter, tsp = teaspoon
children 2 years to under 6 years 5 mL up to 6 times per day (every 4 hours).
children 6 years to under 12 years 10 mL up to 6 times per day (every 4 hours).
adults and children 12 years and over 15 mL up to 6 times per day (every 4 hours).
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
4 KIDS COMPLETE COLD AND MUCUS
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3179 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3179-1 1 in 1 CARTON 07/01/2014 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3179-2 1 in 1 CARTON 10/17/2014 2 19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:54973-3179-4 10 in 1 CARTON 07/01/2014 3 5 mL in 1 POUCH; Type 0: Not a Combination Product 4 NDC:54973-3179-5 1 in 1 CARTON 07/01/2014 4 148 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 07/01/2014 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3179) , pack(54973-3179) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 117337220 pack(54973-3179) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 manufacture(54973-3179) , pack(54973-3179) , label(54973-3179)
