Label: 4 KIDS COMPLETE COLD AND FLU- anas platyrhynchos feather, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid
- NDC Code(s): 54973-3186-1
- 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 November 30, 2018
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- SPL UNCLASSIFIED SECTION
Active ingredients Purpose " HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Anas Barbariae Hepatis Et Cordis Extractum 200C HPUS early onset flu symptoms Bryonia 6X HPUS body aches, headaches, cough Eupatorium Perfoliatum 6X HPUS body aches, headaches, cough Euphrasia Officinalis 6X HPUS runny nose, cough, fever, chills, congestion Gelsemium Sempervirens 6X HPUS aches and pain, fever, fatigue Kali Iodatum 6X HPUS headache, runny nose, fever, sore throat
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
- 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
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 immediately.
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 mucus, unless directed by a licensed health care professional.
A persistent cough may be a sign of a serious condition.
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.
There have been no reports of interactions between this product and ibuprofen or acetaminophen.
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.
- Measure only with the dosing cup provided
- Do not use dosing cup with other products
- On dosing cup, mL = milliliter, tsp = teaspoon
children 2 years to under 6 years 5 mL or 1 teaspoon 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) adults and children 12 years and over 15 mL or 3 teaspoons up to 6 times per day (every 4 hours)
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
INGREDIENTS AND APPEARANCE
4 KIDS COMPLETE COLD AND FLU
anas platyrhynchos feather, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3186 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANAS PLATYRHYNCHOS FEATHER (UNII: 83B65P4796) (ANAS PLATYRHYNCHOS FEATHER - UNII:83B65P4796) ANAS PLATYRHYNCHOS FEATHER 200 [hp_C] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 1 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 6 [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:54973-3186-1 1 in 1 CARTON 04/14/2014 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 04/14/2014 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3186) , pack(54973-3186) Establishment Name Address ID/FEI Business Operations Nexgen Pharma, Inc. 079424083 manufacture(54973-3186) , pack(54973-3186) , label(54973-3186)