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
- 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.
Updated August 29, 2019
If you are a consumer or patient please visit this version.
- Drug Facts
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
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.
- Temporarily relieves the symptoms of the common cold, including:
- runny nose
- post nasal drip
- nasal or chest congestion
- sore throat with accompanying occasional sleeplessness
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 a high fever (over 101°F).
- Cough tends to recur or is accompanied by a high fever, rash or persistent headache.
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 medical professional.
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly.
In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
- Drug Facts (continued)
- 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 years
5 mL at bedtime and every
4 hours during the night
Children 6 years
to under 12 years
10 mL at bedtime and every
4 hours during the night
children 12 years
15 mL at bedtime and every
4 hours during the night
- Do not use if imprinted "SEALED FOR YOURPROTECTION" tamper-evident bottle cap bandis broken or missing.
- The inner packaged bottle is child-resistant.
- Store at room temperature.
- Do not refrigerate.
- SPL UNCLASSIFIED SECTION
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.Close
- PRIMARY PRINCIPAL DISPLAY - 118 mL BOTTLE CARTON
+ also relieves
Post Nasal Drip
4 FL. OZ. (118 mL)
*SEE NOTE ON SIDE PANEL BELOW DRUG FACTS
- 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 liquid
Product 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 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 (028570695) Establishment Name Address ID/FEI Business Operations Nexgen Pharma, Inc. 079424083 manufacture(54973-3375) , pack(54973-3375) , label(54973-3375) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 876754375 manufacture(54973-3375) , pack(54973-3375) , label(54973-3375)