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| Product NDC Code | 63824-943 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mucinex childrens cough and chest congestion mini-melts orange creme |
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| Type | Brand | ||||||
| Pharm Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | GRANULE | ||||||
| RxCUI drug identifier | 2122356 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | RB Health (US) LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each packet) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions empty entire contents of packet onto tongue and swallow for best taste, do not chew granules do not give more than 6 doses in any 24-hour period dose as follows or as directed by a doctor Age Dose adults and Children 12 years of age and over 2 to 4 packets every 4 hours children 6 years to under 12 years of age 1 to 2 packets every 4 hours children 4 years to under 6 years of age 1 packet every 4 hours children under 4 years of age do not use
| Age | Dose |
|---|---|
| adults and Children 12 years of age and over | 2 to 4 packets every 4 hours |
| children 6 years to under 12 years of age | 1 to 2 packets every 4 hours |
| children 4 years to under 6 years of age | 1 packet every 4 hours |
| children under 4 years of age | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aspartame, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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 as may occur with a cold.
Purpose
Information about the drug product’s indications for use.Active ingredients (in each packet) Purposes Dextromethorphan HBr 5 mg Cough suppressant Guaifenesin 100 mg Expectorant
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
Spl product data elements
Usually a list of ingredients in a drug product.Mucinex Childrens Cough and Chest Congestion Mini-Melts Orange Creme Dextromethorphan Hydrobromide and Guaifenesin Dextromethorphan Hydrobromide Dextromethorphan Guaifenesin Guaifenesin aspartame CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED magnesium stearate microcrystalline cellulose POVIDONE, UNSPECIFIED sodium bicarbonate sorbitol stearic acid talc triethyl citrate
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 12 Packet Carton Pediatrician Recommended* NDC 63824-943-12 Mucinex® children's COUGH AND CHEST CONGESTION Dextromethorphan HBr 5 mg - Cough Suppressant Guaifenesin 100 mg - Expectorant ✓ Controls Cough ✓ Relieves Chest Congestion ✓ Thins and Loosens Mucus Ages 4 + years Orange Crème Flavor 12 GRANULE PACKETS PRINCIPAL DISPLAY PANEL - 12 Packet Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Dist. By: RB Health (US) Parsippany, NJ 07054-0224 Made in Germany
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-682-4639 You may also report side effects to this phone number.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use more than directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each packet contains: magnesium 6 mg and sodium 3 mg phenylketonurics : contains phenylalanine 2 mg per packet store at 20-25°C (68-77°F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API