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NDC 63824-0958-64 Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL Details
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat 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; GUAIFENESIN; 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: 63824-0958-64Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 63824-0958-64Last 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: 63824-0958-64Last 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: 63824-0958-64Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63824-0958 |
|---|---|
| Product ID | 63824-958_24e23ded-3bb5-4268-b092-d60f686eba32 |
| Associated GPIs | 43998304100915 |
| GCN Sequence Number | 067928 |
| GCN Sequence Number Description | phenylephrine/DM/acetaminop/GG LIQUID 5-325MG/10 ORAL |
| HIC3 | B4P |
| HIC3 Description | NON-OPIOID ANTITUSS-DECONGESTANT-ANALGESIC-EXPECT |
| GCN | 30579 |
| HICL Sequence Number | 035445 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/DEXTROMETHORPHAN HBR/ACETAMINOPHEN/GUAIFEN |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 200; 5 |
| Active Ingredient Units | mg/10mL; mg/10mL; mg/10mL; mg/10mL |
| Substance Name | ACETAMINOPHEN; 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 63824-0958-64 (63824095864)
| NDC Package Code | 63824-958-64 |
|---|---|
| Billing NDC | 63824095864 |
| Package | 1 BOTTLE in 1 CARTON (63824-958-64) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2020-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06744 |
| Pricing Unit | ML |
| Effective Date | 2022-04-01 |
| NDC Description | CHILD MUCINEX FREEFROM DY COLD |
| 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 14c56f3d-67fd-45ef-a16b-f27604722883 Details
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- nasal congestion
- minor aches and pains
- sore throat
- headache
- stuffy nose
- sinus congestion and pressure
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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.
- 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
- high blood pressure
- thyroid disease
- diabetes
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
When using this product do not use more than directed (see Overdose warning)
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†
DAYTIME
NDC 63824-958-64
Mucinex®
Children's
FREEFROM
MULTI-SYMPTOM
COLD, FLU
& SORE THROAT
ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
GUAIFENESIN – EXPECTORANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
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, FLU AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution |
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| Labeler - RB Health (US) LLC (081049410) |