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| Product NDC Code | 0363-7480 | ||||
|---|---|---|---|---|---|
| Drug Name | Walgreens |
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| Type | Brand | ||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1485599 | ||||
| Application Number | M012 | ||||
| Labeler Name | WALGREENS CO. | ||||
| 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.Drug Facts Active ingredients (in each 5 mL) Guaifenesin, USP 100 mg Phenylephrine HCl, USP 2.5 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 give 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 10 mL every 4 hours Children 4 years to under 6 years 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, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, 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 • temporarily relieves: • nasal congestion due to a cold • stuffy nose
Purpose
Information about the drug product’s indications for use.Purposes Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Walgreens Childrens Stuffy Nose and Cold GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID EDETATE DISODIUM GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE XANTHAN GUM Pink to Red
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.Package Label-Principal Display Panel 4 FL OZ (118 mL Bottle) Walgreens Compare to Children’s Mucinex® Stuffy Nose & Cold active ingredients†† NDC 0363-7480-04 Children's Dye-Free Stuffy Nose & Cold GUAIFENESIN, USP 100 mg /EXPECTORANT PHENYLEPHRINE HCl, USP 2.5 mg/ NASAL DECONGESTANT DYE FREE ALCOHOL FREE • Relief from stuffy nose & chest congestion • Breaks up mucus 4 YEARS & OLDER Mixed Berry Flavor NATURALLY AND ARTIFICIALLY FLAVORED 4 FL OZ (118 mL) DOSAGE CUP PROVIDED TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 Walgreens 100% SATISFACTION GUARANTEED Walgreens.com © 2019 Walgreen Co. Walgreens Children's Stuffy Nose and Cold Syrup
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 • heart disease • high blood pressure • thyroid disease • diabetes • 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 (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? 1-866-467-2748
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 • your child gets nervous, dizzy or sleepless • symptoms do not get better within 7 days or occur with fever • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
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
Storage and handling
Information about safe storage and handling of the drug product.Other information • each 5 mL contains : sodium 3 mg • very low sodium • 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 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. Avoid foods or beverages that contain caffeine.
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