4 KIDS COLD N COUGH- onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid

4 Kids Cold n Cough by

Drug Labeling and Warnings

4 Kids Cold n Cough by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company, Applied Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Allium Cepa 6X HPUS, Hepar Sulph Calc 12X HPUS, Hydrastis 6X HPUS, Natrum Muriaticum 6X HPUS, Phosphorus 12X HPUS, Pulsatilla 6X HPUS, Sulphur 12X HPUS.

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if:

• Symptoms persist for more than 7 days or worsen
• Inflammation, fever or infection develops
• Symptoms are accompanied by a high fever (101F°)
• 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 Poison Control Center immediately. Do not use this product for a 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 package is torn or damaged. 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 2-6 years, one packet (5mL) up to 6 times per day (every 4 hours). Children 6-12 years, 2 packets (10mL) up to 6 times per day (every 4 hours). Adults and children over 12, 3 packets (15mL) up to 6 times per day (every 4 hours).

Inactive ingredients

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

Questions or Comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 5 mL Packet Label

NDC: 54973-3283-1
HOMEOPATHIC

SAFE & EFFECTIVE

Ages
2-12

Natural
Relief

SINCE 1903
Hyland's®
4Kids

Cold 'n Cough*

Nasal Congestion

Runny Nose

Sore Throat

Sneezing

Cough

5 mL
(0.17 FL. OZ.)

INGREDIENTS AND APPEARANCE

4 KIDS COLD N COUGH 
onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3283
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
LICORICE (UNII: 61ZBX54883)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3283-1	5 mL in 1 PACKET; Type 0: Not a Combination Product	05/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		05/13/2016

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	MANUFACTURE(54973-3283) , PACK(54973-3283)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	MANUFACTURE(54973-3283) , PACK(54973-3283)