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

Childrens Nighttime Cold and Mucus by

Drug Labeling and Warnings

Childrens Nighttime Cold and Mucus by is a Homeopathic medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

• Active ingredients:

  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, sneezing

• Silicea 12X HPUS:

  nasal congestion

• Sulphur 12X HPUS:

  cough with thick mucus, chest congestion, nasal congestion

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Drug Facts (continued)

Uses

Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and occasional sleeplessness.

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 health care professional

Persistent cough

A persistent cough may be a sign of a serious condition.

Sore throat warning

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.

In case of emergency

In case of emergency, contact a medical professional or Poison Control Center immediately.

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

Inactive ingredients

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

Principal Display Panel - 118 mL Bottle Label

NDC: 49035-922-01

Compare to

Hyland’s 4 Kids

Cold ’n Mucus

Nighttime

Equate™

Less than 0.2% Alcohol, Sugar free, Dye Free

Homeopathic

Children's

Cold & Mucus*

Nighttime

AGES 2 to 12 YEARS

For Temporary Relief of:

• Mucus & Congestion
• Occasional Sleeplessness
• Runny nose
• Cough

4 FL OZ (118 mL)

*Claims based on traditional homeopathic practice, not

accepted medical evidence. Not FDA evaluated.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-922
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
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	3 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [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
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	3 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LICORICE (UNII: 61ZBX54883)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-922-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/02/2018

Labeler - Wal-Mart Stores, Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(49035-922) , pack(49035-922) , label(49035-922)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(49035-922) , pack(49035-922) , label(49035-922)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		117337220	manufacture(49035-922) , pack(49035-922) , label(49035-922)