Label: KIDS COLD AND COUGH COMBO PACK- onion, chamomile, arabica coffee bean, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris top, sulfur kit
- NDC Code(s): 54973-4110-1, 54973-4111-1, 54973-4112-1
- Packager: Hyland's Consumer Health Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated September 22, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
-
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, post nasal drip Sulphur 12X HPUS.....................................................................................chest congestion, nasal congestion, sneezing, runny nose "HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses*
■ Helps temporarily relieve symptoms of common cold in children, including:
■ runny nose ■ sore throat ■ sneezing ■ cough
■ post nasal drip ■ nasal or chest congestionWarnings
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).
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 4 years
to under 6 years5 mL up to 6 times per day
(every 4 hours).Children 6 years
to under 12 years10 mL up to 6 times per day
(every 4 hours).Adults and children
12 years and over15 mL up to 6 times per day
(every 4 hours). -
NIGHTTIME
Drug Facts
Active ingredients Purpose* Allium Cepa 6X HPUS ....................................................................................watery/runny nose, cold, hacking cough, painful throat Chamomilla 6X HPUS.....................................................................................occasional sleeplessness Coffea Cruda 6X HPUS .................................................................................occasional sleeplessness 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 "HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses*
■ Helps temporarily relieve symptoms of common cold in children at night, including:
■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat
■ nasal or chest congestion ■ occasional sleeplessnessWarnings
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).
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 4 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. - *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
-
Principal Display Panel
Hyland's
NATURALS™
Cold & Cough*
COMBO PACK
NO ALCOHOL, SUGAR, PARABENS or DYES
DAYTIME NIGHTTIME Congestion* Sleeplessness*
Runny Nose* Congestion* Sore Throat* Runny Nose* Cough* Sore Throat* Post Nasal Drip* Cough* Post Nasal Drip* 4 - 12 YEARS
NATURAL
GRAPE FLAVOR
TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)
HOMEOPATHIC
-
INGREDIENTS AND APPEARANCE
KIDS COLD AND COUGH COMBO PACK
onion, chamomile, arabica coffee bean, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris top, sulfur kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-4112 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-4112-1 1 in 1 KIT; Type 0: Not a Combination Product 12/01/2022 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 KIDS COLD AND COUGH NIGHTTIME GRAPE FLAVOR
onion, chamomile, arabica coffee bean, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris top, sulfur liquidProduct Information Item Code (Source) NDC:54973-4111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 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 6 [hp_X] in 1 mL PULSATILLA VULGARIS TOP (UNII: 4F1D271XW0) (PULSATILLA VULGARIS TOP - UNII:4F1D271XW0) PULSATILLA VULGARIS TOP 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) 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:54973-4111-1 1 in 1 CARTON 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 12/01/2022 Part 2 of 2 KIDS COLD AND COUGH DAYTIME GRAPE FLAVOR
onion, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris whole, sulfur liquidProduct Information Item Code (Source) NDC:54973-4110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (PULSATILLA VULGARIS WHOLE - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) 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:54973-4110-1 1 in 1 CARTON 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 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2022 Labeler - Hyland's Consumer Health Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-4112) , pack(54973-4112) , label(54973-4112)