Label: 4 KIDS COLD AND COUGH DAYTIME AND NIGHTTIME- onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal kit
- NDC Code(s): 54973-3075-1, 54973-3375-1, 54973-3378-1
- Packager: Hyland’s 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 27, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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 2 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 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. - *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
- PURPOSE
-
Principal Display Panel - Kids Cold & Cough Daytime Nighttime Combo Pack
Hyland's
NATURALS™
•baby•
Cold & Cough*
COMBO BACK
NO ALCOHOL, SUGAR, PARABENS or DYES
DAYTIME
Congestion*
Runny Nose*
Sore Throat*
Cough*
Post Nasal
Drip*
NIGHTTIME
Sleeplessness*
Congestion*
Runny Nose*
Sore Throat*
Cough*
Post Nasal
Drip*
2 - 12 YEARS
TWP - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)
HOMEOPATHIC
-
INGREDIENTS AND APPEARANCE
4 KIDS COLD AND COUGH DAYTIME AND NIGHTTIME
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3378 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3378-1 1 in 1 CARTON; Type 0: Not a Combination Product 06/08/2018 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 AND 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 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 PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [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 ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) 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 4 KIDS COLD AND COUGH NIGHTTIME
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquidProduct Information Item Code (Source) NDC:54973-3375 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 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 PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [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) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3375-1 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 07/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/08/2018 Labeler - Hyland’s Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3378) , pack(54973-3378) , label(54973-3378)