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| Product NDC Code | 0363-7504 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens chest congestion relief |
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| Type | Brand | ||||
| Pharm Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 310604 | ||||
| Application Number | M012 | ||||
| Labeler Name | WALGREENS COMPANY | ||||
| 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 ingredient (in each 5 mL) 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 • 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, natural and artificial flavors, potassium citrate propylene glycol, purified water, sodium benzoate, 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 rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose
Information about the drug product’s indications for use.Purpose Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Childrens Chest Congestion Relief Guaifenesin Guaifenesin Guaifenesin anhydrous citric acid EDETATE DISODIUM FD&C blue no. 1 FD&C red no. 40 POTASSIUM CITRATE propylene glycol water SODIUM BENZOATE SORBITOL 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 - 120 mL NDC 0363-7504-04 Compare to Children’s Mucinex ® Chest Congestion active ingredient †† children's Chest Congestion Relief GUAIFENESIN 100 mg ORAL SOLUTION, USP/ EXPECTORANT ALCIHOL FREE • Breaks up the mucus that causes congstion AGES 4 YEARS & OLDERS GRAPE FLAVOR NATURALLY AND ARTIFICIALLY FLAVORED 4 FL OZ (120 mL) IMPORTANT: Keep this carton for future reference on full labeling. †Walgreens Pharmacist Survey ††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex ® Chest Congestion DISTRIBUTED BY: WALGREEN CO. 200 WILTMOT RD. DEERFIELD, IL 60015 Walgreens 100% SATISFACTION GUARANTEED walgreen.com ©2020 Walgreens Co. Walgreens Childrens Chest Congestion Relief Grape Flavor
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
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 • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with asthma
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.
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 illness.
Storage and handling
Information about safe storage and handling of the drug product.Other information • each 5 mL contains: sodium 3 mg • store at room temperature • 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.Warnings 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 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 illness. 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