Childrens Cold and Cough Grape Flavor: Homeopathic Product Information

CHILDRENS COLD AND COUGH GRAPE FLAVOR- goldenseal, phosphorus, onion, calcium sulfide, anemone pulsatilla, sulfur and sodium chloride liquid
Walgreen Company

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.

Drug Facts

Active ingredients

Allium Cepa 6X HPUS

Hepar Sulph Calc 12X HPUS

Hydrastis 6X HPUS

Natrum Muriaticum 6X HPUS

Phosphorus 12X HPUS

Pulsatilla 6X HPUS

Sulphur 12X HPUS

“HPUS” indicates that the active ingredients are in the

official Homeopathic Pharmacopœia of the United States.

Allium Cepa 6X HPUS…………….watery/runny nose, cold,hacking cough, painful throat

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

Uses

Temporarily relieves the symptoms of the common cold, including: nasal or chest congestion,runny nose,sore throat,sneezing 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 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.

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

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 cap 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

Children 2 years

to under 6 years

5 mL up to 6 times

per day (every 4 hours)

Children 6 years

to under 12 years

10 mL up to 6 times

per day (every 4 hours)

Adults and children

12 years and over

15 mL up to 6 times

per day (every 4 hours)

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT ACCEPTED

MEDICAL EVIDENCE. NOT FDA EVALUATED.

Questions or comments?

1-800-925-4733

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens

100% SATISFACTION

GUARANTEED

walgreens.com ©2018 Walgreen Co.

PRINCIPAL DISPLAY PANEL-4 FL OZ (118 mL) Bottle Carton

Walgreens

Compare to Hyland’s 4 Kids

Cold ’n Cough Natural Grape Flavor

NDC 0363-9999-01

NEW

children’s

HOMEOPATHIC*

Dye-Free

Cold &

Cough

DYE FREE

ALCOHOL FREE

SUGAR FREE

AGES

2-12

YEARS

GRAPE

FLAVOR

4 FL OZ (118 mL)

carton
(click image for full-size original)
CHILDRENS COLD AND COUGH GRAPE FLAVOR
onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9999
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL
ONION (ONION) ONION 6 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 6 [hp_X] in 1 mL
SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
GLYCERIN
GLYCYRRHIZA GLABRA
WATER
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-9999-01 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0363-9999-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 12/14/2018
Labeler — Walgreen Company (008965063)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 008316655 manufacture (0363-9999)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma, Inc 079424083 manufacture (0363-9999), pack (0363-9999), label (0363-9999)
Establishment
Name Address ID/FEI Operations
Applied Laboratories, Inc. 876754375 manufacture (0363-9999), pack (0363-9999), label (0363-9999)

Revised: 12/2018 Walgreen Company

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