Equate Children's Cold & Mucus Daytime

Equate Children's Cold & Mucus Daytime

Drug Labeling and Warnings

Drug Details

k">

COLD AND MUCUS- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide 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.

----------

Equate Children's Cold & Mucus Daytime

Drug Facts

Active Ingredients

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

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. 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 occurs with asthma, smoking or emphysema or if cough is accompanied by excessive phlegm (mucus).

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 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.

Drug Facts (continued)

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 up to 6 times per day (every 4 hours)

children 6 years to under 12 years

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

adults and children 12 years and over

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

Inactive Ingredients

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

Principal Display Panel - 4 FL OZ (118 mL) Bottle Carton

NDC: 49035-926-01

Equate

Compare to

Hyland’s 4 Kids

Cold ’n Mucus

Alcohol Free, Sugar Free, Dye Free

Homeopathic

Children's

Cold & Mucus*

Daytime

AGES 2 to 12 YEARS

For Temporary Relief of:

  • Mucus & Congestion

  • Runny Nose

  • Cough

*Claims based on traditional

homeopathic practice, not

accepted medical evidence.

Not FDA evaluated.

4 FL OZ (118 mL)

carton

carton2

COLD AND MUCUS 
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49035-926
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [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
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [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: 49035-926-011 in 1 CARTON06/01/2018
1118 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
Labeler - Wal-Mart Stores, Inc. (051957769)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(49035-926) , pack(49035-926) , label(49035-926)
Establishment
NameAddressID/FEIBusiness Operations
Nexgen Pharma, Inc.079424083manufacture(49035-926) , pack(49035-926) , label(49035-926)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.117337220manufacture(49035-926) , pack(49035-926) , label(49035-926)

Revised: 6/2018
 
Wal-Mart Stores, Inc.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.