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| Product NDC Code | 76281-512 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens mucus relief cough - cherry flavor |
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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 | M012 | ||||
| Labeler Name | AptaPharma Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.DRUG FACTS Active ingredients (in each 5 mL teaspoonful) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 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 Age Dose Children 6 years to Under 12 years 1 to 2 teaspoonfuls (tsps) every 4 hours Children 4 years to Under 6 years 1/2 to 1 teaspoonful (tsp) every 4 hours Children under 4 years do not use
| Children 6 years to Under 12 years | 1 to 2 teaspoonfuls (tsps) every 4 hours |
| Children 4 years to Under 6 years | 1/2 to 1 teaspoonful (tsp) 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: anhydrous citric acid, dextrose, D&C red #33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, 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 • temporarily relieves:cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tube
Purpose
Information about the drug product’s indications for use.Purpose Dextromelhorphan HBr, USP ....... Cough Suppressant Guaifenestn,USP ........................Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID DEXTROSE D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE 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.CHILDREN'S MUCUS RELIEF COUGH CHERRY AP SAFE NDC 76281-512-24 Children's Cough Mucus Relief Cough Suppressant Expectorant Cherry Flavor 4 FL OZ (118 mL) DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING *This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Children's Mucinex®Cough. Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 res 512 Cartn 512 Botl
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • each teaspoon contains: sodium 3 mg • store between 20-25°C (68-77°F) • do not refrigerate • dosing cup provided • Keep carton for full direction for use
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944
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 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 • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with asthma 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.
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