Search by Drug Name or NDC

NDC 00363-9999-01 Childrens Cold and Cough Grape Flavor 6; 12; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Childrens Cold and Cough Grape Flavor 6; 12; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Childrens Cold and Cough Grape Flavor is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is ANEMONE PULSATILLA; CALCIUM SULFIDE; GOLDENSEAL; ONION; PHOSPHORUS; SODIUM CHLORIDE; SULFUR.

Product Information

NDC	00363-9999
Product ID	0363-9999_d3b08833-181d-9e6e-e053-2995a90a1e73
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Childrens Cold and Cough Grape Flavor
Proprietary Name Suffix	n/a
Non-Proprietary Name	onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	6; 12; 6; 6; 12; 6; 12
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	ANEMONE PULSATILLA; CALCIUM SULFIDE; GOLDENSEAL; ONION; PHOSPHORUS; SODIUM CHLORIDE; SULFUR
Labeler Name	Walgreen Company
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], O
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-9999-01 (00363999901)

Pricing Information	N/A
NDC Package Code	0363-9999-01
Billing NDC	00363999901
Package	1 BOTTLE, PLASTIC in 1 CARTON (0363-9999-01) / 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-12-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7a2c09e5-0195-138c-e053-2a91aa0ae0a7 Details

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/14/2018

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(0363-9999)

Name	Address	ID/FEI	Business Operations
Establishment
LGM Pharma Solutions, LLC		117549198	manufacture(0363-9999) , pack(0363-9999) , label(0363-9999)

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

Revised: 12/2021

Document Id: d3b08833-181d-9e6e-e053-2995a90a1e73

Set id: 7a2c09e5-0195-138c-e053-2a91aa0ae0a7

Version: 3

Effective Time: 20211221

Search by Drug Name or NDC

NDC 00363-9999-01 Childrens Cold and Cough Grape Flavor 6; 12; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Childrens Cold and Cough Grape Flavor 6; 12; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 00363-9999-01 (00363999901)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7a2c09e5-0195-138c-e053-2a91aa0ae0a7 Details

Drug Facts

Active ingredients

Uses

Warnings

Consult a physician if

Keep this and all medications out of the reach of

children.

Do not use this product for

A persistent cough may be a sign of a serious condition.

Sore throat warning

Do not use if imprinted tamper-evident bottle cap band

is broken or missing.

The inner packaged bottle is child-resistant

Drug Facts (continued)

Directions

Inactive ingredients

SPL UNCLASSIFIED SECTION

Questions or comments?

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

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?

Search by Drug Name or NDC

NDC 00363-9999-01 Childrens Cold and Cough Grape Flavor 6; 12; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Childrens Cold and Cough Grape Flavor 6; 12; 6; 6; 12; 6; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 00363-9999-01 (00363999901)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7a2c09e5-0195-138c-e053-2a91aa0ae0a7 Details

Drug Facts

Active ingredients

Uses

Warnings

Consult a physician if

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

Do not use this product for

A persistent cough may be a sign of a serious condition.

Sore throat warning

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

The inner packaged bottle is child-resistant

Drug Facts (continued)

Directions

Inactive ingredients

SPL UNCLASSIFIED SECTION

Questions or comments?

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

INGREDIENTS AND APPEARANCE

Keep this and all medications out of the reach of

children.

Do not use if imprinted tamper-evident bottle cap band

is broken or missing.