2 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME

Manufacturer
Rite Aid Hdgrts Corp | Seaway Pharma Inc. | Bhargava Phytolab
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:29:52

Label at a glance#

Product2 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME
Active ingredientONION, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, SULFUR, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN
Label structure6 sections

Label contents#

Full prescribing information#

DAYTIME

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Purpose

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

SPL UNCLASSIFIED SECTION

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves the symptoms of common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

OTC - ASK DOCTOR SECTION

Consult a physician if:

  • symptoms persistent for more than 7 days or worsen
  • inflammation, fever or infection develops
  • symptoms are accompanied by high fever (over 101° F)
  • cough tends to recur or is accompanied by high fever, rash or persistent headache
OTC - DO NOT USE SECTION

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a licensed medical professional.

WARNINGS SECTION

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.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
1 teaspoon or 5 mL up to 6 times per day (every 4 hours)
Children 6 years
to under 12 years
2 teaspoons or 10 mL up to 6 times per day (every 4 hours)
Adults and children
12 years and over

3 teaspoons or 15 mL up to 6 times per day (every 4 hours)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

NIGHTTIME

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Purpose

Allium Cepa 6X HPUS

watery/runny nose, cold, hacking cough, painful throat

Chamomilla 6X HPUS

sensitive, irritable, fussy, nocturnal occasional sleeplessness

Coffea Cruda 6X HPUS

occasional sleeplessness, restlessness

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

SPL UNCLASSIFIED SECTION

HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

OTC - PURPOSE SECTION

  • temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying occasional sleeplessness.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - ASK DOCTOR SECTION

Consult a physician if:

  • symptoms persistent for more than 7 days or worsen
  • inflammation, fever or infection develops
  • symptoms are accompanied by high fever (over 101° F)
  • cough tends to recur or is accompanied by high fever, rash or persistent headache
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately.

OTC - DO NOT USE SECTION

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.

WARNINGS SECTION

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.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
1 teaspoon or 5 mL up to 6 times per day (every 4 hours)
Children 6 years
to under 12 years
2 teaspoons or 10 mL up to 6 times per day (every 4 hours)
Adults and children
12 years and over

3 teaspoons or 15 mL up to 6 times per day (every 4 hours)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-866-254-3900.

SPL UNCLASSIFIED SECTION

THIS INFORMATION IS BASED UPON TRADITIONAL HOMEOPATHIC PRACTICE. THESE HAVE NOT BEEN REVIEWED BY FOOD AND DRUG ADMINISTRATION

OTHER SAFETY INFORMATION

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SHRINK BAND OR SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed by:

RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com

PACKAGE LABEL - KIT CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHILDREN'S COLD & COUGH 

Sugar Free, Dye Free

Alcohol free

DAYTIME

Cough
Nasal Congestion
Runny Nose
Sore Throat
Sneezing

NIGHTTIME

Cough
Sneezing
Runny Nose
Sleeplessness
Sore Throat

2-12 YEARS

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

HOMEOPATHIC

catronlabelcatronlabel

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1246-42 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME1 in 1 CARTONLIQUID12 [hp_X] in 1mL2
11822-1246-42 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL2
11822-2233-12 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME1 in 1 CARTONKIT12
11822-2246-42 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL2
11822-2246-42 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME1 in 1 CARTONLIQUID6 [hp_X] in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-12462 TO 12 YEARS CHILDRENS COLD AND COUGH DAY AND NIGHT TIME (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [RITE AID HDGRTS CORP]2Unmatched20241228_75ad8ebf-c8f2-4f9b-802b-fe63fc985ede.zip
11822-22332 TO 12 YEARS CHILDRENS COLD AND COUGH DAY AND NIGHT TIME (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [RITE AID HDGRTS CORP]2Legacy NDC, 5 package rows20241228_75ad8ebf-c8f2-4f9b-802b-fe63fc985ede.zip
11822-22462 TO 12 YEARS CHILDRENS COLD AND COUGH DAY AND NIGHT TIME (ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN) KIT [RITE AID HDGRTS CORP]2Unmatched20241228_75ad8ebf-c8f2-4f9b-802b-fe63fc985ede.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-223311822-2233-1
11822-124611822-1246-4
11822-224611822-2246-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
4a1bc8bc-e476-48c5-b8d4-0bd1bae6397075ad8ebf-c8f2-4f9b-802b-fe63fc985ede2024-12-27WarningsExact identifier
spl id: 4a1bc8bc-e476-48c5-b8d4-0bd1bae63970
spl set id: 75ad8ebf-c8f2-4f9b-802b-fe63fc985ede

Reported adverse events (FAERS/openFDA)#

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