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
Hyland's

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Nighttime Cold n Cough 4 Kids

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 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

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

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)

Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3098-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2010
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/01/2010	12/29/2021

Labeler - Hyland's (028570695)

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

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

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549198	manufacture(54973-3098) , pack(54973-3098) , label(54973-3098)

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

Revised: 12/2021

Document Id: d4509b4c-fa16-efda-e053-2a95a90a66ea

Set id: 794562a5-1e98-4c4f-8fc7-28bb6a3dcaf1

Version: 8

Effective Time: 20211229

Hyland's