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

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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Equate Children's Nighttime Cold & Cough

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

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.

Label

Label2

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-920
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-920-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/02/2018
Labeler - Wal-Mart Stores, Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(49035-920) , pack(49035-920) , label(49035-920)
Establishment
NameAddressID/FEIBusiness Operations
NEXGEN PHARMA, INC.079424083manufacture(49035-920) , pack(49035-920) , label(49035-920)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.117337220manufacture(49035-920) , pack(49035-920) , label(49035-920)

Revised: 7/2018
Document Id: 7047e890-c91d-073a-e053-2991aa0a9be5
Set id: 6a22c084-6c9b-804f-e053-2991aa0a294f
Version: 3
Effective Time: 20180705
 
Wal-Mart Stores, Inc