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#
Contacts and useful links#
Label contents#
Full prescribing information#
DAYTIME
Drug Facts
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
- temporarily relieves the symptoms of common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.
Warnings
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
- 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
Citric Acid, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
NIGHTTIME
Drug Facts
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
- 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
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
- 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
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
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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11822-2233-1 | 2024-12-26 | C162847 | 48780-1 | 1030e365-1104-111a-e063-dadaa90a10e2 | 2 to 12 YEARS CHILDREN'S COLD & COUGH DAY & NIGHT TIME |
| 11822-2233-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1104-111a-e063-dadaa90a10e2 | 2 to 12 YEARS CHILDREN'S COLD & COUGH DAY & NIGHT TIME |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-1246-4 | 2 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME | 1 in 1 CARTON | LIQUID | 12 [hp_X] in 1mL | 2 | |
| 11822-1246-4 | 2 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 mL | 6 [hp_X] in 1mL | 2 |
| 11822-2233-1 | 2 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME | 1 in 1 CARTON | KIT | 1 | 2 | |
| 11822-2246-4 | 2 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 mL | 12 [hp_X] in 1mL | 2 |
| 11822-2246-4 | 2 to 12 YEARS CHILDRENS COLD and COUGH DAY and NIGHT TIME | 1 in 1 CARTON | LIQUID | 6 [hp_X] in 1mL | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-1246 | 2 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] | 2 | Unmatched | 20241228_75ad8ebf-c8f2-4f9b-802b-fe63fc985ede.zip |
| 11822-2233 | 2 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] | 2 | Legacy NDC, 5 package rows | 20241228_75ad8ebf-c8f2-4f9b-802b-fe63fc985ede.zip |
| 11822-2246 | 2 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] | 2 | Unmatched | 20241228_75ad8ebf-c8f2-4f9b-802b-fe63fc985ede.zip |
Products#
Every source-derived product name is available through these pages.
- 2 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
- 2 to 12 YEARS CHILDRENS COLD and COUGH DAY TIME
- ONION
- GOLDENSEAL
- CALCIUM SULFIDE
- SODIUM CHLORIDE
- CHLORIDE ION
- PHOSPHORUS
- ANEMONE PULSATILLA
- SULFUR
- CITRIC ACID MONOHYDRATE
- GLYCERIN
- water
- GLYCYRRHIZA GLABRA
- SODIUM BENZOATE
- 2 to 12 YEARS CHILDRENS COLD and COUGH NIGHT TIME
- MATRICARIA CHAMOMILLA
- ARABICA COFFEE BEAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11822-2233 | 11822-2233-1 |
| 11822-1246 | 11822-1246-4 |
| 11822-2246 | 11822-2246-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ONION | 492225Q21H | ACTIB |
| GOLDENSEAL | ZW3Z11D0JV | ACTIB |
| CALCIUM SULFIDE | 1MBW07J51Q | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| ANEMONE PULSATILLA | I76KB35JEV | ACTIB |
| SULFUR | 70FD1KFU70 | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| water | 059QF0KO0R | IACT |
| GLYCYRRHIZA GLABRA | 2788Z9758H | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| ANEMONE PULSATILLA | I76KB35JEV | ACTIB |
| SULFUR | 70FD1KFU70 | ACTIB |
| CALCIUM SULFIDE | 1MBW07J51Q | ACTIB |
| GOLDENSEAL | ZW3Z11D0JV | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| MATRICARIA CHAMOMILLA | G0R4UBI2ZZ | ACTIB |
| ARABICA COFFEE BEAN | 3SW678MX72 | ACTIB |
| ONION | 492225Q21H | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCYRRHIZA GLABRA | 2788Z9758H | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4a1bc8bc-e476-48c5-b8d4-0bd1bae63970 | 75ad8ebf-c8f2-4f9b-802b-fe63fc985ede | 2024-12-27 | Warnings | 4a1bc8bc-e476-48c5-b8d4-0bd1bae63970 75ad8ebf-c8f2-4f9b-802b-fe63fc985ede |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
