CHILDRENS NIGHTTIME COLD AND COUGH- onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride liquid

Childrens Nighttime Cold and Cough by

Drug Labeling and Warnings

Childrens Nighttime Cold and Cough 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:

  watery/runny nose, cold, hacking cough, sore 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

• 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 that 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.

Drug Facts (continued)

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.

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-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.

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 ery 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: 49035-920-01

Compare to

Hyland's 4 Kids

Cold 'n Cough

Nighttime

Equate™

Alcohol Free, Sugar Free, Dye Free

Homeopathic

Childrens

Cold & Cough*

Nighttime

AGES 2 to 12 YEARS

For Temporary Relief of:

Chest congestion

Occasional sleeplessness

Runny nose

Sore throat

Cough

4 FL OZ (118mL)

*Claims based on traditional homeopathic

practice, not accepted medical evidence.

Not FDA evaluated.

INGREDIENTS AND APPEARANCE

CHILDRENS NIGHTTIME COLD AND COUGH 
onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-920
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
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	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	12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [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
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-920-01	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(49035-920) , pack(49035-920) , label(49035-920)

Establishment
Name	Address	ID/FEI	Business Operations
NEXGEN PHARMA, INC.		079424083	manufacture(49035-920) , pack(49035-920) , label(49035-920)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		117337220	manufacture(49035-920) , pack(49035-920) , label(49035-920)