4 KIDS COLD AND COUGH DAYTIME- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

4 Kids Cold and Cough Daytime by

Drug Labeling and Warnings

4 Kids Cold and Cough Daytime by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc., LGM Pharma Solutions, LLC, Applied Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drugs Facts

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 that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Purpose

Allium Cepa 6X HPUS..........................watery/runny nose, cold, hacking cough, painful throat

Hepar Sulph Calc 12X HPUS................cold, sneezing

Hydrastis 6X HPUS................................rattling/tickling cough, sinus congestion, dry/raw/sore throat

Natrum Muriaticum 6X HPUS................dry cough, sore throat

Phosphorus 12X HPUS.........................hoarse/dry cough, nasal congestion, chest congestion

Pulsatilla 6X HPUS................................moist cough, cold, nasal congestion

Sulphur 12X HPUS................................chest congestion, nasal congestion, sneezing, runny nose

Uses

Temporarily relieves the symptoms of the common cold including: nasal or chest congestion, runny nose, sore throat, sneezing, 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 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 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 medical 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-evident bottle cap band is broken or missing.

The inner packaged bottle is child-resistant

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.

Drug Facts(continued)

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

Questions or comments?

(800) 624-9659

Principal Display Panel - 148 mL Bottle Carton

25% MORE

BONUS PACK

NDC: 54973-3400-1

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

SINCE 1903

Hyland's

4Kiids

Cold 'n

Cough*

DAYTIME

Congestion

Runny Nose

Sore Throat

Sneezing

Cough

ALCOHOL FREE

SUGAR FREE

DYE FREE

4 + 1 = 5 S FL. OZ. (148 mL)

INGREDIENTS AND APPEARANCE

4 KIDS COLD AND COUGH DAYTIME 
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3400
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
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [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
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3400-1	1 in 1 CARTON	08/01/2008
1		148 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		08/01/2008

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(54973-3400) , pack(54973-3400) , label(54973-3400)