Label: 4 KIDS COLD N COUGH GRAPE FLAVOR- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
- NDC Code(s): 54973-3243-1, 54973-3243-2, 54973-3243-3, 54973-3243-4
- 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
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Allium Cepa 6X HPUS
Hepar Sulph Calc 12X HPUS
Hydrastis 6X HPUS
Natrum Muriaticum 6X HPUS
Phosphorus 12X HPUS
Pulsatilla 6X HPUS
Sulphur 12X HPUS
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- watery/runny nose, cold, hacking cough, painful throat
- cold, sneezing
- rattling/tickling cough, sinus congestion, dry/raw/sore throat
- dry cough, sore throat
- hoarse/dry cough, nasal congestion, chest congestion
- moist cough, cold, post nasal drip
- chest congestion, nasal congestion, sneezing, runny nose
- Temporarily relieves the symptoms of common cold in children, including:
- runny nose
- sore throat
- post nasal drip
- nasal or chest congestion
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 high fever (101°F)
- Cough tends to recur or is accompanied by 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 health care 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.
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 up to 6 times per day
(every 4 hours)
Children 6 years
to under 12 years
10 mL up to 6 times per day
(every 4 hours)
Adults and children
12 years and over
15 mL up to 6 times per day
(every 4 hours)
- 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.
Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavoring, Purified Water, Sodium Benzoate.
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
INGREDIENTS AND APPEARANCE
4 KIDS COLD N COUGH GRAPE FLAVOR
onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3243 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 GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 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) GLYCERIN (UNII: PDC6A3C0OX) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) 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:54973-3243-1 1 in 1 CARTON 02/10/2016 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3243-2 1 in 1 CARTON 02/10/2016 2 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:54973-3243-3 5 mL in 1 POUCH; Type 0: Not a Combination Product 02/10/2016 4 NDC:54973-3243-4 1 in 1 CARTON 02/10/2016 4 148 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 02/10/2016 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3243) , pack(54973-3243) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 876754375 manufacture(54973-3243) , pack(54973-3243)