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

4KIDS COMPLETE COLD N FLU by

Drug Labeling and Warnings

4KIDS COMPLETE COLD N FLU by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company. 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 3X 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 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

• 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

Acacia Gum, Lactose N.F.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

NDC: 54973-3241-1
HOMEOPATHIC*

Natural
Relief

Ages
2-12

SINCE 1903
Hyland's

4Kids
Complete
Cold 'n Flu

Body Aches & Headache

Cough & Congestion

Fever & Chills

Sore Throat

125
QUICK-DISSOLVING
TABLETS

SAFE &
EFFECTIVE

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	10/30/2015
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)