| NDC | 54973-3372-1, 54973-3372-2, 54973-3372-3 |
| Set ID | 6f7b2585-2f0e-5938-e053-2a91aa0aa9d1 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Hyland's |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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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
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 that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Uses
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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.
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.
- Drug Facts (continued)
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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?
- PRIMARY PRINCIPAL DISPLAY - 4 FL. OZ. (118 mL) BOTTLE CARTON
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INGREDIENTS AND APPEARANCE
4 KIDS COLD AND MUCUS NIGHTTIME
euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3372 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 CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 3 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 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 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) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3372-2 1 in 1 CARTON 06/27/2018 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3372-1 1 in 1 CARTON 08/01/2018 2 148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:54973-3372-3 5 mL in 1 PACKET; Type 0: Not a Combination Product 06/27/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/27/2018 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 pack(54973-3372) , label(54973-3372) , manufacture(54973-3372) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 876754375 manufacture(54973-3372) , pack(54973-3372) , label(54973-3372)
