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NDC 63824-0950-21 Mucinex Childrens 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL Details
Mucinex Childrens 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL
Mucinex Childrens 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; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 63824-0950-21Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 63824-0950-21Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 63824-0950-21Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63824-0950 |
|---|---|
| Product ID | 63824-950_deabee02-d3dd-3165-e053-2995a90abc23 |
| Associated GPIs | 43994003900935 |
| GCN Sequence Number | 071774 |
| GCN Sequence Number Description | diphenhyd/phenyleph/acetaminop LIQUID 5-325MG/10 ORAL |
| HIC3 | B3O |
| HIC3 Description | 1ST GEN ANTIHISTAMINE-DECONGESTANT-ANALGESIC COMB |
| GCN | 35755 |
| HICL Sequence Number | 035433 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex Childrens |
| Proprietary Name Suffix | Night Time Multi-Symptom Cold |
| Non-Proprietary Name | ACETAMINOPHEN, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 325; 12.5; 5 |
| Active Ingredient Units | mg/10mL; mg/10mL; mg/10mL |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 63824-0950-21 (63824095021)
| NDC Package Code | 63824-950-21 |
|---|---|
| Billing NDC | 63824095021 |
| Package | 1 BOTTLE in 1 CARTON (63824-950-21) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2018-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e048cd53-a3cd-484f-a972-4cb49791dba3 Details
SPL UNCLASSIFIED SECTION
Uses
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
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
- 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
- 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
- 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.
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 5 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 †
NDC 63824-950-21
Mucinex®
Children's
NIGHT TIME
MULTI-SYMPTOM
COLD
Acetaminophen 325 mg - Pain Reliever/Fever Reducer
Diphenhydramine HCl 12.5 mg - Antihistamine/Cough Suppressant
Phenylephrine HCl 5 mg - Nasal Decongestant
- Relieves Stuffy Nose
- Controls Cough
- Relieves Runny Nose
& Sneezing - Relieves Fever & Sore Throat
Ages
6
+
yrs
Very Berry
Flavor Liquid
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
| MUCINEX CHILDRENS
NIGHT TIME MULTI-SYMPTOM COLD
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride solution |
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| Labeler - RB Health (US) LLC (081049410) |