FDA.reportPublic FDA data

Childrens Cold and Cough Day and Night Twin Pack

Manufacturer
Wal-Mart Stores, Inc
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:36:19

Label at a glance#

ProductChildrens Cold and Cough Day and Night Twin Pack
Active ingredientONION, ARABICA COFFEE BEAN, CALCIUM SULFIDE, PHOSPHORUS, ANEMONE PULSATILLA, SODIUM CHLORIDE, MATRICARIA CHAMOMILLA, SULFUR, GOLDENSEAL
Label structure17 sections

Indications and uses

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

Dosage and administration

Shake well before using. Measure only with the dosing cup provided. Do not use dosing cup with other products. On dosing cup, mL = milliliter.

Label contents#

Full prescribing information#

DAYTIME

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
Active ingredientsPurpose
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, sore throat
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUS

hoarse/dry cough, nasal congestion, chest congestion

Pulsatilla 6X HPUSmoist cough, cold, nasal congestion
Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of the 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 - 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 a high fever (over 101°F)
  • Cough tends to recur or is accompanied by a 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.

SPL UNCLASSIFIED 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 medical professional.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

In case of emergency or accidental overdose,

contact a medical professional or Poison Control

Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before using.
  • Measure only with the dosing cup provided.
  • Do not use dosing cup with other products.
  • On dosing cup, mL = milliliter.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Children 2 years

to under 6 years

5mL up to 6 times

per day (every 4 hours)

Children 6 years

to under 12 years

10mL up to 6 times

per day (every 4 hours)

Adults and children

12 years and over

15mL up to 6 times

per day (every 4 hours)

Other information

OTHER SAFETY INFORMATION

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
  • The inner packaged bottle is child-resistant.
  • Store at room temperature.
  • Do not refrigerate.

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
OTC - PURPOSE SECTION
Active ingredients Purpose
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, sore throat
Chamomilla 6X HPUSsensitive, irritable, fussy, nocturnal occasional sleeplessness
Coffea Cruda 6X HPUSoccasional sleeplessness, restlessness
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling, tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUSmoist cough, cold, nasal congestion
Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE 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.

SPL UNCLASSIFIED SECTION

Consult a physician if:

  • Symptoms persist for more than 7 days or worsen
  • Inflammation, fever or infection develops

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of

children.

SPL UNCLASSIFIED 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 medical professional.

SPL UNCLASSIFIED SECTION

A persistent cough may be a sign of a serious

condition.

OTC - DO NOT USE SECTION

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.

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before using.
  • 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 years5mL at bedtime and every 4 hours during the night

or as necessary

Children 6 years to under 12 years10mL at bedtime and every 4 hours during the night or as necessary
Adults and children 12 years and over15mL at bedtime and every 4 hours during the night or as necessary

Other information

OTHER SAFETY INFORMATION

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
  • The inner packaged bottle is child-resistant.
  • Store at room temperature.
  • Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

*Claims based on traditional homeopathic

practice, not accepted medical evidence.

Not FDA evaluated.

Dosage and Administration

RECENT MAJOR CHANGES SECTION

 Directions

Shake well before using.

 Measure only with the dosing cup provided.

 Do not use dosing cup with other products.

 On dosing cup, mL = milliliter.

Removed 2 teaspoon

Primary Principal Display Panel - Children's Cold & Cough Day & Night Value Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE PACK

NDC 49035-95-01

Equate™

Compare to

Hyland’s 4 Kids

Cold ‘n Cough Day

& Night Value Pack

active ingredients

Children's

Alcohol-Free, Sugar-Free Dye-Free

Homeopathic

Cold & Cough*

Daytime

Ages 2 to12 years

For Temporary Relief of:

  • Nasal congestion
  • Runny nose
  • Sore throat
  • Sneezing
  • Cough

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

4 FL OZ (118mL) Daytime

8 FL OZ (236mL) TOTAL

Children's

Alcohol-Free, Sugar-Free Dye-Free

Homeopathic

Cold & Cough*

Nighttime

Ages 2 to12 years

For Temporary Relief of:

  • Chest congestion
  • Occasional sleeplessness
  • Runny nose
  • Sore throat
  • Sneezing
  • Cough

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

4 FL OZ (118mL) Nighttime

CCKDNFL240CTNPLWMR1CCKDNFL240CTNPLWMR1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-925-012021-12-23C16284748780-1c7ccaba7-1d43-fd44-e053-dadaa90aa01bEquate Children’s Cold & Cough Day & Night Value Pack
49035-925-012021-07-23C16284748780-1c7ccaba7-1d43-fd44-e053-dadaa90aa01bEquate Children’s Cold & Cough Day & Night Value Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-920-01Childrens Cold and Cough Day and Night Twin Pack118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL7
49035-925-01Childrens Cold and Cough Day and Night Twin Pack1 in 1 CARTONKIT17
49035-927-01Childrens Cold and Cough Day and Night Twin Pack118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL7
49035-927-01Childrens Cold and Cough Day and Night Twin Pack1 in 1 CARTONLIQUID6 [hp_X] in 1mL7

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-92549035-925-01
49035-92049035-920-01
49035-92749035-927-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCYRRHIZA GLABRA2788Z9758HIACT
WATER059QF0KO0RIACT
ONION492225Q21HACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
SULFUR70FD1KFU70ACTIB
GOLDENSEALZW3Z11D0JVACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
GOLDENSEALZW3Z11D0JVACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SULFUR70FD1KFU70ACTIB
ONION492225Q21HACTIB
CALCIUM SULFIDE1MBW07J51QACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Cold and Cough Day and Night Twin PackONION,MATRICARIA CHAMOMILLA,ARABICA COFFEE BEAN,CALCIUM SULFIDE,GOLDENSEAL,SODIUM CHLORIDE,PHOSPHORUS,ANEMONE PULSATILLA AND SULFURWal-Mart Stores, Inc70454f5a-b5ca-8d30-e053-2991aa0a1afc2025-12-19WarningsExact identifier
ndc (package): 49035-925-01
ndc (package): 49035-927-01
ndc (package): 49035-920-01
ndc (product): 49035-925
ndc11 (package): 49035092001
ndc11 (package): 49035092501
ndc11 (package): 49035092701
spl id: 4651c400-1954-9ba4-e063-6294a90a8532
spl set id: 70454f5a-b5ca-8d30-e053-2991aa0a1afc
Cold and CoughONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEALWal-Mart Stores, Inc.69349b4d-6c5b-7121-e053-2991aa0a35942022-12-15WarningsExact identifier
ndc (package): 49035-927-01
ndc (product): 49035-927
ndc11 (package): 49035092701

Reported adverse events (FAERS/openFDA)#

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