| NDC | 54973-3243-2, 54973-3245-1, 54973-3282-1 |
| Set ID | 2af06fbf-df77-4bc7-bebe-a7460003308a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Hyland's |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients Purpose "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. 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 - 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.
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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 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
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients Purpose "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. 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
(0.0000016% Alkaloids, calculated)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 - 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.
-
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?
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PRINCIPAL DISPLAY PANEL - Kit Carton
Natural Grape Flavor!
Natural
ReliefNDC 54973-3282-1
HOMEOPATHICAges
2-12SINCE 1903
Hyland's
4Kids
Cold 'n Cough*Day & Night Combo Pack
DAYTIME
Nasal Congestion
Runny Nose
Sore Throat
Sneezing
CoughNatural Grape
FlavorALCOHOL FREE
SUGAR FREE
DYE FREE8 FL. OZ. (236 mL) Daytime
NIGHTTIME
Chest Congestion
Occasional Sleeplessness
Runny Nose
Sore Throat
Sneezing
CoughNatural Grape
FlavorALCOHOL FREE
SUGAR FREE
DYE FREE4 FL. OZ. (118 mL) Nighttime
12 FL. OZ. (354 mL) TOTAL
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INGREDIENTS AND APPEARANCE
4 KIDS COLD N COUGH DAY AND NIGHT COMBO PACK
onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, sulfur, matricaria recutita, arabica coffee bean, and strychnos nux-vomica seed kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3282 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3282-1 1 in 1 CARTON 06/17/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 236 mL Part 2 1 BOTTLE, PLASTIC 118 mL Part 1 of 2 4 KIDS COLD N COUGH GRAPE FLAVOR
onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquidProduct Information Item Code (Source) NDC:54973-3243 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) (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 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) GLYCERIN (UNII: PDC6A3C0OX) LICORICE (UNII: 61ZBX54883) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor GRAPE (Natural Grape Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3243-2 236 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 02/10/2016 Part 2 of 2 4KIDS COLD N COUGH NIGHTTIME GRAPE FLAVOR
onion, matricaria recutita, arabica coffee bean, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, and sulfur liquidProduct Information Item Code (Source) NDC:54973-3245 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 MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 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 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 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) GLYCERIN (UNII: PDC6A3C0OX) LICORICE (UNII: 61ZBX54883) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor GRAPE (Natural Grape Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3245-1 118 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 04/18/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 06/17/2016 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 MANUFACTURE(54973-3282) , PACK(54973-3282) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 876754375 MANUFACTURE(54973-3282) , PACK(54973-3282)