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

4 Kids Complete Cold and Flu by

Drug Labeling and Warnings

4 Kids Complete Cold and Flu by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company, LGM Pharma Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

Temporarily relieves the symptoms of the common cold and flu including body aches and headaches, cough and congestion, fever, chills, and sore throat.

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
• 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.

Do not use if imprinted tamper band is broken or missing.

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.

Directions

• 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

Citric Acid, Glycyrrhiza Extract, Purified Water, Sodium Benzoate, Vegetable Glycerine.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

New!

Natural
Relief

NDC: 54973-3186-1
HOMEOPATHIC

Ages
2-12

SINCE 1903
Hyland's
4Kids

Complete
Cold 'n Flu *

Body Aches & Headache

Cough & Congestion

Fever & Chills

Sore Throat

LESS THAN 0.1% ALCOHOL
SUGAR FREE
DYE FREE

SAFE &
EFFECTIVE

4 FL. OZ. (118 mL)

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)