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

Childrens Cold and Cough Grape Flavor by

Drug Labeling and Warnings

Childrens Cold and Cough Grape Flavor by is a Homeopathic medication manufactured, distributed, or labeled by Walgreen Company, Standard Homeopathic Company, LGM Pharma Solutions, LLC, Applied Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

*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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9999-01	1 in 1 CARTON	12/14/2018
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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	Business Operations
Standard Homeopathic Company		008316655	manufacture(0363-9999)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc		079424083	manufacture(0363-9999) , pack(0363-9999) , label(0363-9999)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(0363-9999) , pack(0363-9999) , label(0363-9999)