Childrens Cold and Cough Grape Flavor

Manufacturer
Walgreen Company | Standard Homeopathic Company | LGM Pharma Solutions, LLC | Applied Laboratories, Inc.
Effective date
2021-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:15:15

Label at a glance#

ProductChildrens Cold and Cough Grape Flavor
Active ingredientGOLDENSEAL, PHOSPHORUS, ONION, CALCIUM SULFIDE, ANEMONE PULSATILLA, SULFUR, SODIUM CHLORIDE
Label structure8 sections

Indications and uses

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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Consult a physician if

SPL UNCLASSIFIED SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use this product for

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Sore throat warning

SPL UNCLASSIFIED SECTION

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.

OTC - DO NOT USE SECTION

The inner packaged bottle is child-resistant

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

In case of emergency, contact a medical professional or Poison Control Center immediately.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-925-4733

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

cartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9999-01Childrens Cold and Cough Grape Flavor1 in 1 CARTONLIQUID13
0363-9999-01Childrens Cold and Cough Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9999CHILDRENS COLD AND COUGH GRAPE FLAVOR (ONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFUR) LIQUID [WALGREEN COMPANY]3Current NDC, Legacy NDC, 2 package rows20211222_7a2c09e5-0195-138c-e053-2a91aa0ae0a7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-99990363-9999-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Cold and Cough Grape FlavorONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURWalgreen Company7a2c09e5-0195-138c-e053-2a91aa0ae0a72021-12-21WarningsExact identifier
ndc (package): 0363-9999-01
ndc (product): 0363-9999
ndc11 (package): 00363999901
spl id: d3b08833-181d-9e6e-e053-2995a90a1e73
spl set id: 7a2c09e5-0195-138c-e053-2a91aa0ae0a7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.