Label: KIDS COLD AND COUGH DAYTIME GRAPE FLAVOR- onion, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris whole, sulfur liquid
- NDC Code(s): 54973-4110-1
- Packager: Hyland's Consumer Health 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.
Drug Label Information
Updated August 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
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Drug Facts
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, post nasal drip Sulphur 12X HPUS................................................................ chest congestion, nasal congestion, sneezing, runny nose "HPUS" is the Homeopathic Pharmacopoeia of the United States.
- Uses
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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).
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Directions
■ Use as directed. ■ Do not refrigerate. ■ 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 4 years
to under 6 years5 mL up to 6 times per day
(every 4 hours).Children 6 years
to under 12 years10 mL up to 6 times per day
(every 4 hours).Adults and children
12 years and over15 mL up to 6 times per day
(every 4 hours). - 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
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INGREDIENTS AND APPEARANCE
KIDS COLD AND COUGH DAYTIME GRAPE FLAVOR
onion, calcium sulfide, golden seal, sodium chloride, phosphorus, pulsatilla vulgaris whole, sulfur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-4110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL 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 PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (PULSATILLA VULGARIS WHOLE - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) 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:54973-4110-1 1 in 1 CARTON 12/01/2022 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 12/01/2022 Labeler - Hyland's Consumer Health Inc. (008316655)
