BABY NIGHTTIME MUCUS PLUS COLD RELIEF- calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla liquid

Baby Nighttime Mucus Plus Cold Relief by

Drug Labeling and Warnings

Baby Nighttime Mucus Plus Cold Relief by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Allium Cepa 6X HPUS

Bryonia Alba 6X HPUS

Chamomilla 3X HPUS

Coffea Cruda 3X HPUS

Euphrasia Officinalis 6X HPUS

Hepar Sulph Calc 12X HPUS

Hydrastis 6X HPUS

Natrum Muriaticum 6X HPUS

Phosphorus 30X HPUS

Pulsatilla 6X HPUS

Rumex Crispus 6X HPUS

Silicea 12X HPUS

Sulphur 12X HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Purpose

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,occasional sleeplessness due to mucus in throat

Natrum Muriaticum 6X HPUS...accumulation of mucus in throat, cough up mucus

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 a high fever (over 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.

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 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 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 at

  bedtime and every 6 hours

  during the night or as necessary.

• Children 1 to 3 years of age:

  5 mL or 1 teaspoon at bedtime

  and every 4 hours during the

  night or as necessary.

Inactive ingredients

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

Questions or comments?

(800) 624-9659

Principal Display Panel - 148 mL Bottle Label Carton

25% FREE

BONUS PACK

NDC: 54973-3371-1

HOMEOPATHIC

Ages

6 months+

NATURAL

RELIEF

SINCE 1903

Hyland's

baby

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 + 1 = 5 FL. O Z. (148 mL)

INGREDIENTS AND APPEARANCE

BABY NIGHTTIME MUCUS PLUS COLD RELIEF 
calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3371
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
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
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	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
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	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
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3371-1	1 in 1 CARTON	11/01/2018
1		148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-3371-2	1 in 1 CARTON	11/01/2018
2		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 54973-3371-3	2.5 mL in 1 PACKET; Type 0: Not a Combination Product	11/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/01/2018

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(54973-3371) , pack(54973-3371) , label(54973-3371)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(54973-3371) , pack(54973-3371) , label(54973-3371)