CHILDRENS COLD AND MUCUS DAY AND NIGHT TWIN PACK- childrens cold and mucus day and night twin pack 
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.

----------

Equate Children's Cold & Mucus Day & Night Twin Pack

DAYTIME

Drug Facts

Active ingredients

Purpose

Bryonia Alba 6X HPUS

stubborn mucus in throat,cough with yellowish mucus

Euphrasia Officinalis 6X HPUS

cough with mucus in chest

Hepar Sulph Calc 12X HPUS

HPUS...cough up mucus, mucus rattle with cough, stubborn mucus in chest

Natrum Muriaticum 30X 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

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

Uses

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

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.

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.

In case of emergency or accidental overdose,

contact a medical professional or Poison Control

Center immediately .

Drug Facts (continued)

Directions

  • Shake well before using.
  • Measure only with the dosing cup provided.
  • Do not use dosing cup with other products.
  • On dosing cup, mL = milliliter.

Children 2 years to under 6 years

5mL or 1 teaspoon up to 6 times per day (every 4 hours)

Children 6 years to under 12 years

10mL or 2 teaspoons up to 6 times per day (every 4 hours)

Adults and children 12 years and over

15mL or 3 teaspoons up to 6 times per day (every 4 hours)

Inactive ingredients

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

Other information

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
  • The inner packaged bottle is child-resistant.
  • Store at room temperature.
  • Do not refrigerate.

NIGHTTIME

Drug Facts

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.

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.

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 a high fever (over 101°F)
  • Cough tends to recur or is accompanied by a high fever, rash or persistent headache

Keep this and all medications out of the reach of children.

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: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

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

Directions

  • Shake well before using.
  • Measure only with the dosing cup provided.
  • Do not use dosing cup with other products.
  • On dosing cup, mL = milliliter.

Children 2 years to under 6 years

5mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary

Children 6 years to under 12 years

10mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary

Adults and children 12 years and over

15mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

Other information

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
  • The inner packaged bottle is child-resistant.
  • Store at room temperature.
  • Do not refrigerate.

Inactive ingredients

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

Principal Display Panel - Kit Carton

VALUE PACK

Equate™

NDC 49035-924-01

Compare to

Hyland’s 4 Kids

Cold ‘n Mucus

Value Pack

active

ingredients

Children's

Alcohol free, Sugar free, Dye-Free

Homeopathic

Cold & Mucus*

Daytime

Ages 2 to 12 years

For Temporary Relief of:

*Claims based on traditional homeopathic practice, not

accepted medical evidence. Not FDA evaluated.

4 FL OZ (118mL) Daytime

8 FL OZ (236mL) TOTAL

Children’s

Less than 0.2% Alcohol, Sugar free, Dye free

Homeopathic

Cold & Mucus*

Nighttime

Ages 2 to 12 years

For Temporary Relief of:

*Claims based on traditional homeopathic practice, not

accepted medical evidence.Not FDA evaluated.

4 FL OZ (118mL) Nighttime

Carton Value Pack

CHILDRENS COLD AND MUCUS DAY AND NIGHT TWIN PACK 
childrens cold and mucus day and night twin pack kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-924
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-924-011 in 1 CARTON; Type 0: Not a Combination Product07/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 118 mL
Part 21 BOTTLE, PLASTIC 118 mL
Part 1 of 2
COLD AND MUCUS 
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid
Product Information
Item Code (Source)NDC:49035-926
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [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) PHOSPHORUS30 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-926-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2018
Part 2 of 2
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
Item Code (Source)NDC:49035-922
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA3 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [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) PHOSPHORUS30 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
LICORICE (UNII: 61ZBX54883)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-922-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/01/2018
Labeler - Wal-Mart Stores, Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(49035-924)
Establishment
NameAddressID/FEIBusiness Operations
Nexgen Pharma, Inc.079424083manufacture(49035-924) , pack(49035-924) , label(49035-924)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.876754375manufacture(49035-924) , pack(49035-924) , label(49035-924)

Revised: 11/2019
Document Id: 96da88b8-ae0b-6e67-e053-2995a90a98ff
Set id: 70a74383-302f-eddb-e053-2a91aa0a5822
Version: 3
Effective Time: 20191108
 
Wal-Mart Stores, Inc