| NDC | 54973-3075-1, 54973-3098-1, 54973-3177-1 |
| Set ID | f624dede-ef5f-44e9-b86d-4bd545ea1571 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Hylands Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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DAYTIME
Drug Facts
Active ingredients Purpose Allium Cepa 6X HPUS watery, runny nose, cold, hacking cough, painful throat 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, nasal congestion Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose "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 a 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.
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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, tsp = teaspoon
Children 2 years to under 6 years 5 mL or 1 teaspoon up to 6 times per day (every 4 hours) Children 6 years to under 12 years 10 mL or 2 teaspoons up to 6 times per day (every 4 hours) Adults and children 12 years and over 15 mL or 3 teaspoons up to 6 times per day (every 4 hours) - Inactive ingredients
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NIGHTTIME
Drug Facts
Active ingredients Purpose 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 Nux Vomica 6X HPUS tired, difficulty falling asleep, frequent waking Phosphorus 12X HPUS hoarse/dry cough, nasal congestion, chest congestion Pulsatilla 6X HPUS moist cough, cold, nasal congestion Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States
- Uses
-
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 a 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.
-
Directions
- Measure only with the dosing cup provided
- Do not use dosing cup with other products
- On dosing cup, 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?
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PRINCIPAL DISPLAY PANEL - Kit Carton
Natural
ReliefNDC 54973-3177-1
HOMEOPATHIC*Ages
2-12SINCE 1903
Hyland's®4 Kids
Cold 'n Cough*
Day & Night Value Pack
DAYTIME
Nasal Congestion
Runny Nose
Sore Throat
Sneezing
Cough
ALCOHOL FREE
SUGAR FREE
DYE FREE4 FL. OZ. (118 mL) Daytime
NIGHTTIME
Chest Congestion
Occasional Sleeplessness
Runny Nose
Sore Throat
Sneezing
Cough
ALCOHOL FREE
SUGAR FREE
DYE FREE4 FL. OZ. (118 mL) Nighttime
8 FL. OZ. (236 mL) TOTAL
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INGREDIENTS AND APPEARANCE
4 KIDS COLD N COUGH DAY AND NIGHT VALUE PACK
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, goldenseal, strychnos nux-vomica seed, coffee bean, and chamomile kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3177 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3177-1 1 in 1 CARTON; Type 0: Not a Combination Product 12/01/2013 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 118 mL Part 2 1 BOTTLE, PLASTIC 118 mL Part 1 of 2 COLD N COUGH 4 KIDS
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquidProduct Information Item Code (Source) NDC:54973-3075 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 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) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 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:54973-3075-1 118 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 08/01/2008 Part 2 of 2 NIGHTTIME COLD N COUGH 4 KIDS
onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur liquidProduct Information Item Code (Source) NDC:54973-3098 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 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) (CHLORIDE ION - UNII:Q32ZN48698) 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 PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X] in 1 mL COFFEE BEAN (UNII: JFH385Y744) (COFFEE BEAN - UNII:JFH385Y744) COFFEE BEAN 6 [hp_X] in 1 mL CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 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) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3098-1 118 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 07/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2013 Labeler - Hylands Inc. (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3177) , pack(54973-3177) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 manufacture(54973-3177) , pack(54973-3177) , label(54973-3177)