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| Product NDC Code | 70000-0630 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens mucus and cough relief |
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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 | LIQUID | ||||
| RxCUI drug identifier | 1020138 | ||||
| Application Number | part341 | ||||
| Labeler Name | CARDINAL HEALTH 110, LLC. DBA LEADER | ||||
| 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 5 mL) Dextromethorphan HBr 5 mg Guaifenesin 100 mg
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 do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products mL=milliliter Age Dose children 6 years to under 12 years 5 mL-10 mL every 4 hours children 4 years to under 6 years 2.5 mL - 5 mL every 4 hours children under 4 years do not use
| Age | Dose |
| children 6 years to under 12 years | 5 mL-10 mL every 4 hours |
| children 4 years to under 6 years | 2.5 mL - 5 mL every 4 hours |
| children under 4 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum
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 drain bronchial tubes and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants the impulse to cough to help your child get to sleep the intensity of coughing
Purpose
Information about the drug product’s indications for use.PURPOSE Cough suppressant Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Childrens Mucus and Cough Relief Dextromethorphan HBr, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID DEXTROSE, UNSPECIFIED FORM D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN METHYLPARABEN POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL SODIUM HYDROXIDE SUCRALOSE XANTHAN GUM
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 LEADER NDC 70000-0630-1 Children's Mucus & Cough Relief Dextromethorphan HBr, 5mg Guaifenesin 100 mg cough Suppressant Expectorant Cherry Flavor Ages 4+ Years Controls Cough Relieves Chest Congestion Thins and Loosen Mucus COMPARE TO CHILDREN'S MUCINEX ® COUGH active ingredients* 4 FL OZ (118mL) LDR_552_CARTON 552_LDR_LABLE
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 THE CHILD HAS persistent or chronic cough such as occurs with asthma cough that occurs with 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 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.
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 (1-800-222-1222) 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 COMMENTS? call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est
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 is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION each 5 mL contains: potassium 5 mg, sodium 5 mg store between 20 to 25°C (68 to 77°F) do not refrigerate dosing cup provided
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.WARNING .
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