| NDC | 54973-3377-1, 54973-3377-2, 54973-3377-3 |
| Set ID | 7923e59a-f62c-44df-e053-2991aa0afc1e |
| 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
Allium Cepa 6X HPUS ..........watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS ......... sensitive, irritable, fussy, nocturnal occasional sleeplessness
Coffea Cruda 6X HPUS........occasional sleeplessness, restlessness
Hepar Sulph Calc 12X HPUS................ cold, sneezing
Hydrastis 6X HPUS ..................rattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUS...dry cough, sore throat
Phosphorus 12X HPUS..................hoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUS.........................moist cough, cold, post nasal drip
Sulphur 12X HPUS .........................chest congestion, nasal congestion, sneezing, runny nose
- Uses
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Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly.Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema.
A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).
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Directions
Use as directed. Do not refrigerate. Shake well before using. Measure only with the dosing cup provided. Do not use
dosing cup with other products. On dosing cup, mL = milliliter.Children 2 years
to under 6 years5 mL at bedtime and every 4 hours
during the night until relieved.Children 6 years
to under 12 years10 mL at bedtime and every 4 hours
during the night until relieved.Adults and children
12 years and over15 mL at bedtime and every 4 hours
during the night until relieved. - Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- OTHER SAFETY INFORMATION
- PACKAGE LABEL- 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR
onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3377 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 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 PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 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) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3377-1 1 in 1 CARTON 11/01/2018 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3377-2 5 mL in 1 PACKET; Type 0: Not a Combination Product 11/01/2018 3 NDC:54973-3377-3 1 in 1 CARTON 11/01/2018 3 148 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 11/01/2018 Labeler - Hyland's (028570695) Registrant - Standard Homeopathic Company (Hyland's) (008316655) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3377) , pack(54973-3377) , label(54973-3377) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 080253323 manufacture(54973-3377) , pack(54973-3377) , label(54973-3377) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 876754375 manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)
