Indications and uses
temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion runny nose sneezing cough controls cough to help your child get to sleep temporarily reduces fever
Childrens Mucinex
- Manufacturer
- RB Health (US) LLC
- Effective date
- 2022-02-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:06:58
Label at a glance#
ProductChildrens Mucinex Night Time Multi-Symptom Cold
Active ingredientAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Label structure10 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning ) if needed, repeat dose every 4 hours while symptoms last do not give more than 5 days unless directed by a doctor measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter children 6 to under 12 years of a...
Storage and handling
each 10 mL contains: sodium 6 mg store between 20-25°C (68-77°F) dosing cup provided do not refrigerate
Contacts and useful links#
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 mg | Pain reliever/fever reducer |
| Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- runny nose
- sneezing
- cough
- controls cough to help your child get to sleep
- temporarily reduces fever
Warnings
Liver warning
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
Sore throat warning
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
- 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 drug 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 your child has
- 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 your child is
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- 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
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 for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see Overdose warning)
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 days unless directed by a doctor
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
- children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours; do not give more than 5 doses in any 24-hour period
- children under 6 years of age: do not use
Other information
- each 10 mL contains: sodium 6 mg
- store between 20-25°C (68-77°F)
- dosing cup provided
- do not refrigerate
Inactive ingredients
Questions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
SPL UNCLASSIFIED SECTION
Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
Made in England
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
New!
NDC 63824-600-64
Children's
Mucinex®
NIGHT TIME
Multi-Symptom
Cold
Pain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
✓ Stuffy Nose
✓ Cough
✓ Runny Nose & Sneezing
✓ Fever & Sore Throat
Age 6+
Mixed Berry
Flavor Liquid
4 FL OZ
(118 mL)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-600-64 | 2022-03-04 | C162847 | 48780-1 | 9d75b9d0-fc7f-f424-e053-dadaa90a57ce | Children's Mucinex® Night Time Multi-Symptom Cold |
| 63824-600-64 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fc7f-f424-e053-dadaa90a57ce | Children's Mucinex® Night Time Multi-Symptom Cold |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-600-64 | ML - Milliliter | 63824-600 | b1b51d79-0b6d-4d82-bbc6-2e3a5c49664f | 1 | 2013-11-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 3 | |
| Diphenhydramine Hydrochloride | ACTIVE INGREDIENT | TC2D6JAD40 | 3 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 3 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 3 | |
| Diphenhydramine | ACTIVE MOIETY | 8GTS82S83M | 3 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 3 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | 3 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 3 | |
| FD&C blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 3 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 3 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| propyl gallate | INACTIVE INGREDIENT | 8D4SNN7V92 | 3 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 3 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 3 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 3 | |
| trisodium citrate dihydrate | INACTIVE INGREDIENT | B22547B95K | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | 3 |
Products#
Every source-derived product name is available through these pages.
- Childrens Mucinex Night Time Multi-Symptom Cold
- Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
- Acetaminophen
- Diphenhydramine Hydrochloride
- Diphenhydramine
- Phenylephrine Hydrochloride
- Phenylephrine
- anhydrous citric acid
- edetate disodium
- FD&C blue no. 1
- FD&C red no. 40
- glycerin
- propylene glycol
- propyl gallate
- water
- sodium benzoate
- sorbitol
- sucralose
- trisodium citrate dihydrate
- xanthan gum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-600 | 63824-600-64 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| glycerin | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SUSPENSION / ORAL | 5013 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| sorbitol | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | GRANULE, FOR SUSPENSION / ORAL | 30 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION, SOLUTION / INTRAVENOUS | 1188 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / SUBCUTANEOUS | 101 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 81 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | ENEMA / RECTAL | 60 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | CAPSULE / ORAL | 8.5 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION, CONCENTRATE / INTRAVENOUS | 60 mg | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SUSPENSION / RESPIRATORY (INHALATION) | 2 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / NASAL | 5 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| propyl gallate | PROPYL GALLATE | 8D4SNN7V92 | OINTMENT / TOPICAL | NA | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / INTRAVENOUS | 0.03 %w/v | ||
| sucralose | SUCRALOSE | 96K6UQ3ZD4 | TABLET / ORAL | 45 mg | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | CAPSULE / ORAL | 35 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SOLUTION / ORAL | 0.33 mg/5ml | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | INJECTION, SUSPENSION / INTRAVITREAL | 0.17 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| propyl gallate | PROPYL GALLATE | 8D4SNN7V92 | GEL / TOPICAL | 0.05 %w/w | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| sorbitol | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| FD&C blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 mg | ||
| sucralose | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| trisodium citrate dihydrate | TRISODIUM CITRATE DIHYDRATE | B22547B95K | SOLUTION / INTRAOCULAR | 27 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v |
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 |
|---|---|---|---|---|---|---|
| 769b4612-265d-433c-8e7b-4703ece1c77f | 12948a0b-417f-4e2d-9944-f03f69b765e7 | 2022-02-25 | Warnings | 769b4612-265d-433c-8e7b-4703ece1c77f 12948a0b-417f-4e2d-9944-f03f69b765e7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.