| NDC | 54973-3250-1, 54973-3250-2 |
| Set ID | a27c429b-afdb-4fef-b91c-3fbd35557d6f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Hyland's |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients Purpose Allium Cepa 6X HPUS runny nose with mucus, hacking cough, sore throat Bryonia Alba 6X HPUS stubborn mucus in throat,cough with yellowish mucus Chamomilla 3X HPUS irritability, fussiness, occasional sleeplessness Coffea Cruda 3X HPUS occasional sleeplessness, restlessness 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 Hydrastis 6X HPUS cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat Natrum Muriaticum 6X HPUS accumulation of mucus in throat, cough up mucus Nux Vomica 6X HPUS
(0.0000016% Alkaloids, calculated)tired, difficulty falling asleep, frequent waking 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 Sulphur 12X HPUS cough with thick mucus, chest congestion, nasal congestion "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Uses
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Warnings
As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if:
- Symptoms persist for more than 7 days or worsen
- Inflammation, fever or infection develops
- Symptoms are accompanied by high fever (101°F)
- Cough tends to recur or is accompanied by high fever, rash or persistent headache
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.
Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.
A persistent cough may be a sign of a serious condition.
- Drug Facts (continued)
- SPL UNCLASSIFIED SECTION
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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 or 1 teaspoon at bedtime and every 4 hours during the night or as necessary Children 6 years to under 12 years 10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary Adults and children 12 years and over 15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary - Inactive ingredients
- Questions or comments?
- PURPOSE
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
4KIDS COLD N MUCUS NIGHTTIME
onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, and sulfur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3250 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 3 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [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 GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [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 SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) LICORICE (UNII: 61ZBX54883) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3250-1 1 in 1 CARTON 04/29/2016 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3250-2 5 mL in 1 POUCH; Type 0: Not a Combination Product 11/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/29/2016 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3250) , pack(54973-3250) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 117337220 pack(54973-3250) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 manufacture(54973-3250) , pack(54973-3250)
