Indications and 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.
Childrens Nighttime Cold and Cough
- Manufacturer
- Wal-Mart Stores, Inc
- Effective date
- 2022-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:44:16
Label at a glance#
ProductChildrens Nighttime Cold and Cough
Active ingredientONION, ARABICA COFFEE BEAN, CALCIUM SULFIDE, PHOSPHORUS, SULFUR, GOLDENSEAL, ANEMONE PULSATILLA, MATRICARIA CHAMOMILLA, SODIUM CHLORIDE
Label structure6 sections
Dosage and administration
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 5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary Children 6 years ery to under 12 years 10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary Adults and children 12 years and over 15 mL...
Label contents#
Full prescribing information#
Drug Facts
Active ingredients
OTC - PURPOSE SECTION
Active ingredients | Purpose |
Allium Cepa 6X HPUS | watery/runny nose, cold, hacking cough, sore 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 |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia 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.
Drug Facts (continued)
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 persist for more than 7 days or worsen • Inflammation, fever or infection develops
• Symptoms are accompanied by high fever (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 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.
SPL UNCLASSIFIED SECTION
A persistent cough may be a sign of a serious condition.
Sore throat warning
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.
OTC - DO NOT USE SECTION
Do not use if imprinted tamper-evident bottle band is broken or missing.
SPL UNCLASSIFIED SECTION
The inner packaged bottle is child-resistant.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 | 5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary |
Children 6 years ery to under 12 years | 10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary |
Adults and children 12 years and over | 15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary |
Inactive ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Principal Display Panel - 118 mL Bottle Label
NDC 49035-920-01
Compare to
Hyland's 4 Kids
Cold 'n Cough
Nighttime
Equate™
Alcohol Free, Sugar Free, Dye Free
Homeopathic
Childrens
Cold & Cough*
Nighttime
AGES 2 to 12 YEARS
For Temporary Relief of:
Chest congestion
Occasional sleeplessness
Runny nose
Sore throat
Cough
4 FL OZ (118mL)
*Claims based on traditional homeopathic
practice, not accepted medical evidence.
Not FDA evaluated.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49035-920-01 | 2021-12-21 | C162847 | 48780-1 | c7ccaba7-15f6-fd44-e053-dadaa90aa01b | Equate Children's Nighttime Cold & Cough |
| 49035-920-01 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-15f6-fd44-e053-dadaa90aa01b | Equate Children's Nighttime Cold & Cough |
Products#
Every source-derived product name is available through these pages.
- Childrens Nighttime Cold and Cough
- onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride
- CITRIC ACID MONOHYDRATE
- SODIUM BENZOATE
- GLYCERIN
- GLYCYRRHIZA GLABRA
- WATER
- ONION
- ARABICA COFFEE BEAN
- CALCIUM SULFIDE
- PHOSPHORUS
- SULFUR
- GOLDENSEAL
- ANEMONE PULSATILLA
- MATRICARIA CHAMOMILLA
- SODIUM CHLORIDE
- SODIUM CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49035-920 | 49035-920-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GLYCYRRHIZA GLABRA | 2788Z9758H | IACT |
| WATER | 059QF0KO0R | IACT |
| ONION | 492225Q21H | ACTIB |
| ARABICA COFFEE BEAN | 3SW678MX72 | ACTIB |
| CALCIUM SULFIDE | 1MBW07J51Q | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| SULFUR | 70FD1KFU70 | ACTIB |
| GOLDENSEAL | ZW3Z11D0JV | ACTIB |
| ANEMONE PULSATILLA | I76KB35JEV | ACTIB |
| MATRICARIA CHAMOMILLA | G0R4UBI2ZZ | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Childrens Cold and Cough Day and Night Twin Pack | ONION,MATRICARIA CHAMOMILLA,ARABICA COFFEE BEAN,CALCIUM SULFIDE,GOLDENSEAL,SODIUM CHLORIDE,PHOSPHORUS,ANEMONE PULSATILLA AND SULFUR | Wal-Mart Stores, Inc | 70454f5a-b5ca-8d30-e053-2991aa0a1afc | 2025-12-19 | Warnings | 49035-920-01 49035092001 |
| 087d39ed-2670-7d7e-e063-6294a90ad85a | 6a22c084-6c9b-804f-e053-2991aa0a294f | 2023-10-24 | Warnings | 6a22c084-6c9b-804f-e053-2991aa0a294f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.