FDA.reportPublic FDA data

Children's Delsym

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-05-27
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:58:44

Label at a glance#

ProductChildrens Delsym Cough Plus Cold Night Time
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help your child get to sleep

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning ) measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period children u...

Storage and handling

each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F) do not refrigerate

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 10 mL)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • nasal congestion
    • minor aches and pains
    • sore throat
    • headache
    • runny nose
    • sneezing
  • temporarily reduces fever
  • controls cough to help your child get to sleep

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on the skin
  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed (see Overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period
  • children under 6 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate 1, xanthan gum

1 may contain this ingredient

Questions?

OTC - QUESTIONS SECTION

1-866-682-4639
You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US), Parsippany, NJ 07054-0224
Made in England

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63824-212-64

Ages 6 Years+

Children's

Delsym ®

COUGH + Cold

Night Time

Acetaminophen(Pain Reliever/Fever Reducer)

Diphenhydramine HCl (Antihistamine/Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

  • Relieves Cough
  • Relieves

    Stuffy Nose
  • Relieves

    Sore Throat
  • Reduces Fever

BerryFlavor

4 fl oz (118 mL)

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN10
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD10
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY10
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY10
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY10
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY10
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

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

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-212-642020-05-06C16284748780-19d75b9cf-dbb3-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus Cold Night Time
63824-212-642020-05-06C16284748780-19d75b9cf-dbb3-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus Cold Night Time
63824-212-662020-05-06C16284748780-19d75b9cf-dbb3-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus Cold Night Time
63824-212-662020-05-06C16284748780-19d75b9cf-dbb3-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus Cold Night Time
63824-212-642020-01-31C16284748780-19d75b9cf-dbb3-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus Cold Night Time
63824-212-642020-01-31C16284748780-19d75b9cf-dbb3-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus Cold Night Time
63824-212-662020-01-31C16284748780-19d75b9cf-dbb3-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus Cold Night Time
63824-212-662020-01-31C16284748780-19d75b9cf-dbb3-f424-e053-dadaa90a57ceChildren's Delsym ® Cough Plus Cold Night Time

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63824-212-64Childrens DelsymCough Plus Cold Night Time1 in 1 CARTONSOLUTION110
63824-212-64Childrens DelsymCough Plus Cold Night Time118 mL in 1 BOTTLESOLUTION11810
63824-212-66Childrens DelsymCough Plus Cold Night Time180 mL in 1 BOTTLESOLUTION18010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-212-66ML - Milliliter63824-2129e80fb7d-fee3-4ba7-8b32-f18139897a9212013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D2
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD402
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ2
AcetaminophenACTIVE MOIETY362O9ITL9D2
DiphenhydramineACTIVE MOIETY8GTS82S83M2
PhenylephrineACTIVE MOIETY1WS297W6MV2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL2
edetate disodiumINACTIVE INGREDIENT7FLD91C86K2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA2
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
propyl gallateINACTIVE INGREDIENT8D4SNN7V922
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU2
sorbitolINACTIVE INGREDIENT506T60A25R2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD42
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95K2
waterINACTIVE INGREDIENT059QF0KO0R2
xanthan gumINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-21263824-212-66, 63824-212-64

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92026-05-13weekly-update2026-06-03 18:02:47

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 51 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CAPSULE / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, FILM COATED / ORAL0.04 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, FILM COATED / ORAL0.04 mgExact identifier — unii+route
18 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / ORAL1200 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92SUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
18 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92SUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
18 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii+route
18 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii+route
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CAPSULE / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / ORAL1200 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92CAPSULE / ORAL7 mgExact identifier — unii+route
18 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92SUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii+route
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION / ORAL1200 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii+route
18 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propyl gallatePROPYL GALLATE8D4SNN7V92TABLET, FILM COATED / ORAL0.04 mgExact identifier — unii+route
18 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION / ORAL84 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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 Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
ndc (package): 63824-212-64
ndc (package): 63824-212-66
ndc (product): 63824-212
ndc11 (package): 63824021266
ndc11 (package): 63824021264
spl id: 52d0fea6-91c1-c0ad-e063-6294a90ad3ca
spl set id: 00689aa5-ed39-4c9a-92b8-105d2c0e2e15

Reported adverse events (FAERS/openFDA)#

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