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Childrens chest congestion relief - Medication Information

Product NDC Code 0363-7504
Drug Name

Childrens chest congestion relief

Type Brand
Pharm Class Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE]
Active Ingredients
Guaifenesin 100 mg/5ml
Route ORAL
Dosage Form SOLUTION
RxCUI drug identifier 310604
Application Number M012
Labeler Name WALGREENS COMPANY
Packages
Package NDC Code Description
0363-7504-04 1 bottle in 1 carton (0363-7504-04) / 120 ml in 1 bottle
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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
AgeDose
children 6 years to under 12 years5 mL – 10 mL every 4 hours
children 4 years to under 6 years2.5 mL – 5 mL every 4 hours
children under 4 yearsdo 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
IMPORTANT: Keep this carton for future reference on full labeling.

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