Label: KIDS COUGH AND MUCUS DAYTIME GRAPE FLAVOR- bryonia alba root,calcium sulfide,pulsatilla vulgaris whole,ferrosoferric phosphate,phosphorus,antimony potassium tartrate,ipecac,rumex crispus root liquid
- NDC Code(s): 54973-4113-1
- 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 April 23, 2024
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 Antimonium Tartaricum 15X HPUS............................................... cough Bryonia Alba 15X HPUS............................................................... sore throat, mucus in throat, cough Ferrum Phosphoricum 12X HPUS ............................................... mucus in throat, cough Hepar Sulph Calc 12X HPUS....................................................... mucus in chest, cough Ipecacuanha 12X HPUS .............................................................. cough, sore throat Phosphorus 15X HPUS ............................................................... runny nose, chest or nasal congestion Pulsatilla 12X HPUS ................................................................... mucus in chest or throat, cough, sneezing Rumex Crispus 6X HPUS ........................................................... runny nose, sneezing "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 COUGH AND MUCUS DAYTIME GRAPE FLAVOR
bryonia alba root,calcium sulfide,pulsatilla vulgaris whole,ferrosoferric phosphate,phosphorus,antimony potassium tartrate,ipecac,rumex crispus root liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-4113 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 15 [hp_X] in 1 mL ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE 15 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 12 [hp_X] in 1 mL PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (PULSATILLA VULGARIS WHOLE - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE 12 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) 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:54973-4113-1 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) Establishment Name Address ID/FEI Business Operations Hyland's INC 008316655 manufacture(54973-4113) , label(54973-4113) , pack(54973-4113)
