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NDC 63824-0959-64 Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime 325; 10; 5; 1.25 mg/10mL; mg/10mL; mg/10mL; mg/10mL Details
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime 325; 10; 5; 1.25 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE.
Product Information
| NDC | 63824-0959 |
|---|---|
| Product ID | 63824-959_e7ec13b8-bdf3-49b4-ad45-ddc211e653ab |
| Associated GPIs | 43995904222020 |
| GCN Sequence Number | 080843 |
| GCN Sequence Number Description | triprolid/phenyleph/DM/acetam LIQUID 5-325MG/10 ORAL |
| HIC3 | B3P |
| HIC3 Description | NON-OPIOID ANTITUS-1STGEN ANTIHIST-DECON-ANALGESIC |
| GCN | 47825 |
| HICL Sequence Number | 046408 |
| HICL Sequence Number Description | TRIPROLIDINE HCL/PHENYLEPHRINE/DEXTROMETHORPHN/ACETAMINOPHEN |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Triprolidine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 5; 1.25 |
| Active Ingredient Units | mg/10mL; mg/10mL; mg/10mL; mg/10mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63824-0959-64 (63824095964)
| NDC Package Code | 63824-959-64 |
|---|---|
| Billing NDC | 63824095964 |
| Package | 1 BOTTLE in 1 CARTON (63824-959-64) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2020-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 84e7be8f-2785-45ef-9c44-de05394fcd99 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 1625 mg in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
Allergy alert
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
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
- 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
- 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
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not use more than directed (see Overdose warning)
- excitability may occur, especially in children
- may cause marked drowsiness
- 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.
Directions
- 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 4 doses in any 24-hour period
- children under 6 years of age: do not use
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Pediatrician Recommended†
NIGHTTIME
NDC 63824-959-64
Mucinex®
Children's
FREEFROM
MULTI-SYMPTOM
COLD & FLU
NIGHTTIME
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
TRIPROLIDINE HCl – ANTIHISTAMINE
FREEFROM
ARTIFICIAL FLAVORS, COLORS, & DYES • ALCOHOL & SUGAR
ELDERBERRY
& CHERRY NATURAL FLAVOR
AGES
6+ YRS.
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
| MUCINEX CHILDRENS FREEFROM MULTI-SYMPTOM COLD AND FLU NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution |
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| Labeler - RB Health (US) LLC (081049410) |
Revised: 3/2021
Document Id: e7ec13b8-bdf3-49b4-ad45-ddc211e653ab
Set id: 84e7be8f-2785-45ef-9c44-de05394fcd99
Version: 2
Effective Time: 20210316