Label: COLD AND COUGH- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
- NDC Code(s): 49035-927-01
- Packager: Wal-Mart Stores, 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.
Updated November 15, 2019
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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, nasal congestion Sulphur 12X HPUS chest congestion, nasal congestion, sneezing, runny nose
"HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
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.
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)
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
Principal Display Panel - 4 FL OZ (118 mL) Bottle Carton
Hyland’s 4 Kids
Cold ’n Cough
Alcohol Free, Sugar Free, Dye Free
Cold & Cough*
AGES 2 to 12 YEARS
For Temporary Relief of:
- Nasal Congestion
- Runny Nose
- Sore Throat
*Claims based on traditional
homeopathic practice, not
accepted medical evidence.
Not FDA evaluated.
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
COLD AND COUGH
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-927 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 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-927-01 1 in 1 CARTON 06/01/2018 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 06/01/2018 Labeler - Wal-Mart Stores, Inc. (051957769) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(49035-927) , pack(49035-927) , label(49035-927) Establishment Name Address ID/FEI Business Operations Nexgen Pharma, Inc. 079424083 manufacture(49035-927) , pack(49035-927) , label(49035-927) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 876754375 manufacture(49035-927) , pack(49035-927) , label(49035-927)