Equate Children's Cold & Cough

Equate Children's Cold & Cough

Drug Labeling and Warnings

Drug Details

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COLD AND COUGH- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal 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 Cold & Cough

Drug Facts

Active Ingredients

Active ingredientsPurpose
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUS

hoarse/dry cough, nasal congestion, chest congestion

Pulsatilla 6X HPUSmoist cough, cold, nasal congestion
Sulphur 12X HPUSchest 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 nasal and chest congestion, runny nose, sore throat, sneezing and cough.

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 medical 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.

Do not use if imprinted tamper 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 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: 49035-927-01

Equate

Compare to

Hyland’s 4 Kids

Cold ’n Cough

Alcohol Free, Sugar Free, Dye Free

Homeopathic

Children's

Cold & Cough*

Daytime

AGES 2 to 12 YEARS

For Temporary Relief of:

  • Nasal Congestion

  • Runny Nose

  • Sore Throat

  • Sneezing

  • Cough

*Claims based on traditional

homeopathic practice, not

accepted medical evidence.

Not FDA evaluated.

4 FL OZ (118 mL)

carton 1

carton2

COLD AND COUGH 
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49035-927
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [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
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49035-927-011 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(49035-927) , pack(49035-927) , label(49035-927)
Establishment
NameAddressID/FEIBusiness Operations
Nexgen Pharma, Inc.079424083manufacture(49035-927) , pack(49035-927) , label(49035-927)
Establishment
NameAddressID/FEIBusiness Operations
Applied Laboratories, Inc.876754375manufacture(49035-927) , pack(49035-927) , label(49035-927)

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


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