BABY NIGHTTIME MUCUS COLD RELIEF- onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, rumex crispus root, silicon dioxide, and sulfur liquid

Baby Nighttime Mucus Cold Relief by

Drug Labeling and Warnings

Baby Nighttime Mucus Cold Relief by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company, LGM Pharma Solutions, LLC, Applied Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Allium Cepa 6X HPUS	runny nose with mucus, hacking cough, sore throat
Bryonia Alba 6X HPUS	stubborn mucus in throat, cough with yellowish mucus
Chamomilla 3X HPUS	irritability, fussiness, occasional sleeplessness
Coffea Cruda 3X HPUS	occasional sleeplessness, restlessness
Euphrasia Officinalis 6X HPUS	cough with mucus in chest
Hepar Sulph Calc 12X HPUS	cough up mucus, mucus rattle with cough, stubborn mucus in chest
Hydrastis 6X HPUS	cough with mucus, dry, sore throat, sleeplessness due to mucus in throat
Natrum Muriaticum 6X HPUS	accumulation of mucus in throat, cough up mucus
Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated)	tired, difficulty falling asleep, frequent waking
Phosphorus 30X HPUS	cough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUS	accumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUS	runny nose and sneezing
Silicea 12X HPUS	nasal congestion
Sulphur 12X HPUS	cough with thick mucus, chest congestion, nasal congestion

Uses

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and irritability, fussiness and occasional sleeplessness.

Warnings

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, 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 preprinted tamper band is broken or missing.

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

• Measure only with the dosing syringe provided
• Do not use dosing syringe with other products
• On dosing syringe, mL = milliliter, tsp = teaspoon

• Children under 6 months of age: consult a licensed health care professional before using this product
• Children 6 months to under 1 year of age: 2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours)
• Children 1 to 3 years of age: 5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

Inactive ingredients

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

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Ages 6 months+

NDC: 54973-3251-1

HOMEOPATHIC

SINCE 1903

Hyland's
Baby

Natural
Relief

Nighttime
Mucus +
Cold Relief

LOOSENS MUCUS,
RELIEF OF CONGESTION,
AND OCCASIONAL
SLEEPLESSNESS DUE
TO COLDS*

►No Artificial Flavors,
Dyes or Parabens

LESS THAN 0.2% ALCOHOL

4 FL.OZ. (118 mL)

INGREDIENTS AND APPEARANCE

BABY NIGHTTIME MUCUS COLD RELIEF 
onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, rumex crispus root, silicon dioxide, and sulfur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3251
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
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	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) (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	30 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [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)
LICORICE (UNII: 61ZBX54883)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3251-1	1 in 1 CARTON	12/28/2015
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3251-2	2.5 mL in 1 POUCH; Type 0: Not a Combination Product	12/23/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/28/2015

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3251) , pack(54973-3251)

Establishment
Name	Address	ID/FEI	Business Operations
NEXGEN PHARMA, INC.		079424083	manufacture(54973-3251) , pack(54973-3251)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		117337220	pack(54973-3251)