NIGHTTIME COLD N COUGH 4 KIDS- onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur liquid

Nighttime Cold n Cough 4 Kids by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Drug Facts

Active ingredients		Purpose
Allium Cepa 6X HPUS		watery, runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS		sensitive, irritable, fussy,nocturnal occasional sleeplessness
Coffea Cruda 6X HPUS		occasional sleeplessness, restlessness
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
Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated)		tired, difficulty falling asleep, frequent waking
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

"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 cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.

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

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.

KEEP OUT OF REACH OF CHILDREN

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.

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 at bedtime and every 4 hours during the night or as necessary
• Children 6 years to under 12 years: 10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
• Adults and children 12 years and over: 15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

SPL UNCLASSIFIED SECTION

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.

Inactive ingredients

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

Questions or comments?

(800) 624-9659

PURPOSE

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC: 54973-3098-1
HOMEOPATHIC

Natural

Relief

Ages
2-12

SINCE 1903
Hyland's®

4 Kids

Cold 'n
Cough*

NIGHTTIME

Chest Congestion
Occasional Sleeplessness
Runny Nose
Sore Throat
Sneezing
Cough

ALCOHOL FREE
SUGAR FREE
DYE FREE

SAFE &
EFFECTIVE

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD N COUGH 4 KIDS 
onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3098
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	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
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
COFFEE BEAN (UNII: JFH385Y744) (COFFEE BEAN - UNII:JFH385Y744)	COFFEE BEAN	6 [hp_X]  in 1 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	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

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: 54973-3098-1	1 in 1 CARTON	07/01/2010
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3098-2	19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2010	12/31/2017
3	NDC: 54973-3098-3	5 mL in 1 PACKET; Type 0: Not a Combination Product	07/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2010

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3098) , pack(54973-3098)

Establishment
Name	Address	ID/FEI	Business Operations
NEXGEN PHARMA, INC.		079424083	manufacture(54973-3098) , pack(54973-3098)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		117337220	manufacture(54973-3098) , pack(54973-3098)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	manufacture(54973-3098) , pack(54973-3098)