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NDC 63824-0956-64 Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL Details
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 63824-0956-64Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 63824-0956-64Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
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: 63824-0956-64Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63824-0956 |
|---|---|
| Product ID | 63824-956_1f64f023-32c3-43dd-88d7-f259966fef11 |
| Associated GPIs | 43997303100960 |
| GCN Sequence Number | 066559 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 5-2.5 MG/5 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 28875 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5; 100; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE 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 63824-0956-64 (63824095664)
| NDC Package Code | 63824-956-64 |
|---|---|
| Billing NDC | 63824095664 |
| Package | 1 BOTTLE in 1 CARTON (63824-956-64) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2020-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06999 |
| Pricing Unit | ML |
| Effective Date | 2022-04-01 |
| NDC Description | CHILDREN'S MUCINEX FREEFROM LQ |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5, 6 |
| Classification for Rate Setting | B |
| As of Date | 2022-06-29 |
Standard Product Labeling (SPL)/Prescribing Information SPL c07dad99-87b0-419b-9230-7c22a77ecf9e Details
SPL UNCLASSIFIED SECTION
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
Warnings
Do not use 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Directions
- do not give more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
| Age | Dose |
|---|---|
| children 6 to under 12 years of age | 10 mL every 4 hours |
| children 4 to under 6 years of age | 5 mL every 4 hours |
| children under 4 years of age | do not use |
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Pediatrician Recommended†
DAYTIME
NDC 63824-956-64
Mucinex®
Children's
FREEFROM
MULTI-SYMPTOM
COLD
& STUFFY NOSE
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
GUAIFENESIN – EXPECTORANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
FREEFROM
ARTIFICIAL FLAVORS, COLORS, & DYES • ALCOHOL & SUGAR
HONEY
& BERRY NATURAL FLAVOR
AGES
4+ YRS.
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
| MUCINEX CHILDRENS FREEFROM MULTI-SYMPTOM COLD AND STUFFY NOSE
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution |
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| Labeler - RB Health (US) LLC (081049410) |