Label: DEFEND COLD AND MUCUS- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone patens, rumex crispus root, and silicon dioxide liquid
- NDC Code(s): 54973-3183-1
- Packager: Hyland's 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 December 12, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active Ingredients Purpose "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Bryonia 6X HPUS stubborn mucus in throat, cough with yellowish mucus Euphrasia Officinalis 6X HPUS cough with mucus in chest Hepar Sulph Calc 12X HPUS cough up mucus, mucus rattle with cough, stubborn mucus in chest Natrum Muriaticum 30X HPUS accumulation of mucus in throat, cough up mucus Phosphorus 30X HPUS cough with expectoration of yellow mucus, chest congestion Pulsatilla 6X HPUS accumulation of mucus, discharge of thick, yellowish mucus, loose cough Rumex Crispus 6X HPUS runny nose, sneezing Silicea 12X HPUS nasal congestion - Uses
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Warnings
As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if:
- Symptoms persist for more than 7 days or worsen
- Cough tends to recur or is accompanied by a high fever, rash or persistent headache
Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center.
Do not use this product for persistent or chronic cough such as occurs with asthma, smoking or emphysema or if cough is accompanied by excessive phlegm (mucus).
A persistent cough may be a sign of a serious condition.
Do not use if imprinted tamper band is broken or missing.
In case of emergency, 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.
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Directions
- Measure only with the dosing cup provided
- Do not use dosing cup with other products
- On dosing cup, mL = millimeter, tsp = teaspoon
adults and children 12 years and over 15 mL or 3 teaspoons up to 6 times per day (every 4 hours) children 6 years to under 12 years 10 mL or 2 teaspoons up to 6 times per day (every 4 hours) children 2 years to under 6 years 5 mL or 1 teaspoon up to 6 times per day (every 4 hours) - Inactive Ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
DEFEND COLD AND MUCUS
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone patens, rumex crispus root, and silicon dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3183 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X] in 1 mL PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA PATENS WHOLE 6 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3183-1 1 in 1 CARTON 07/01/2014 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 07/01/2014 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3183) , pack(54973-3183) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 manufacture(54973-3183) , pack(54973-3183) , label(54973-3183)
