Label: 4KIDS COMPLETE COLD N FLU- cairina moschata heart/liver autolysate, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet
- NDC Code(s): 54973-3241-1
- 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 3, 2015
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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 3X 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 asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care 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.
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.
Children 2 years to under 6 years dissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required Children 6 years to under 12 years dissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required Adults and children 12 years and over dissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton
INGREDIENTS AND APPEARANCE
4KIDS COMPLETE COLD N FLU
cairina moschata heart/liver autolysate, bryonia alba root, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3241 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE (UNII: RN2HC612GY) (CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - UNII:RN2HC612GY) CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 200 [hp_C] BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X] EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 3 [hp_X] Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color WHITE Score no score Shape ROUND Size 5mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3241-1 1 in 1 CARTON 1 125 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 10/30/2015 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 MANUFACTURE(54973-3241) , PACK(54973-3241)