Label: 4 KIDS COLD AND COUGH NIGHTTIME- onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid
- NDC Code(s): 54973-3375-1, 54973-3375-2, 54973-3375-3
- Packager: Hyland's Consumer Health Inc.
- Category: HUMAN OTC DRUG LABEL
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 28, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
-
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” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
- Uses*
-
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).
-
Directions
■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.
■ Measure only with dosing cup provides. ■ Do not use dosing cup with other products.
■ On dosing cup, mL = milliliter.
Children 2 years
to under 6 years
5 mL at bedtime and every 4 hours
during the night until relieved.
Children 6 years
to under 12 years
10 mL at bedtime and every 4 hours
during the night until relieved.
Adults and children
12 years and over
15 mL at bedtime and every 4 hours
during the night until relieved.
- Inactive ingredients
- Questions?
- *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 - 4 FL. OZ. (118 mL) Carton
-
INGREDIENTS AND APPEARANCE
4 KIDS COLD AND COUGH NIGHTTIME
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3375 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 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 ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3375-1 1 in 1 CARTON 07/01/2018 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3375-2 5 mL in 1 PACKET; Type 0: Not a Combination Product 07/01/2018 12/15/2021 3 NDC:54973-3375-3 1 in 1 CARTON 07/01/2018 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 07/01/2018 Labeler - Hyland's Consumer Health Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)
