Label: 4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR- onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquid
- NDC Code(s): 54973-3377-1, 54973-3377-2, 54973-3377-3
- 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 September 5, 2019
If you are a consumer or patient please visit this version.
- Drug Facts
Allium Cepa 6X HPUS,Chamomilla 6X HPUS,Coffea Cruda 6X HPUS,Hepar Sulph Calc 12X HPUS,Hydrastis 6X HPUS
Natrum Muriaticum 6X, Phosphorus 12X HPUS,Pulsatilla 6X HPUS, Sulphur 12X HPUS
“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
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
- Temporarily relieves symptoms of common cold in children especially at night, 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
Adults and children
12 years and over
15 mL at bedtime and every
4 hours during the night
- Other information
- Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
- The inner packaged bottle is child-resistant.
- Store at room temperature.
- Do not refrigerate.
- Inactive ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract,Natural Grape Flavor Purified Water, Sodium Benzoate.Close
- Questions or comments?
- Principal Display Panel - 4 FL OZ (118 mL) Bottle Carton
Cold 'n Cough*
Natural Grape Flavor
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 NATURAL GRAPE FLAVOR
onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3377 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 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 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) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3377-1 1 in 1 CARTON 11/01/2018 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3377-2 5 mL in 1 PACKET; Type 0: Not a Combination Product 11/01/2018 3 NDC:54973-3377-3 1 in 1 CARTON 11/01/2018 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 11/01/2018 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3377) , pack(54973-3377) , label(54973-3377) Establishment Name Address ID/FEI Business Operations Nexgen Pharma, Inc. 079424083 manufacture(54973-3377) , pack(54973-3377) , label(54973-3377) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 876754375 manufacture(54973-3377) , pack(54973-3377) , label(54973-3377)