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Maximum strength cough plus chest congestion dm - Medication Information

Product NDC Code 0363-0115
Drug Name

Maximum strength cough plus chest congestion dm

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]
Active Ingredients
Dextromethorphan hydrobromide 10 mg/1
Guaifenesin 200 mg/1
Route ORAL
Dosage Form CAPSULE, GELATIN COATED
RxCUI drug identifier 1111663
Application Number M012
Labeler Name WALGREENS
Packages
Package NDC Code Description
0363-0115-20 1 blister pack in 1 carton (0363-0115-20) / 20 capsule, gelatin coated in 1 blister pack
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each softgel) Purposes Dextromethorphan HBr, USP 10 mg Cough suppressant Guaifenesin, USP 200 mg Expectorant
Active ingredients (in each softgel)Purposes
Dextromethorphan HBr, USP 10 mgCough suppressant
Guaifenesin, USP 200 mgExpectorant

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 12 softgels in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 softgels every 4 hours children under 12 years do not use
agedose
adults and children 12 years and over2 softgels every 4 hours
children under 12 yearsdo not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C Red-40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, special sorbitol, titanium dioxide

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 bronchial tubes

Purpose

Information about the drug product’s indications for use.
Active ingredients (in each softgel) Purposes Dextromethorphan HBr, USP 10 mg Cough suppressant Guaifenesin, USP 200 mg Expectorant
Active ingredients (in each softgel)Purposes
Dextromethorphan HBr, USP 10 mgCough suppressant
Guaifenesin, USP 200 mgExpectorant

Spl product data elements

Usually a list of ingredients in a drug product.
MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM Dextromethorphan Hydrobromide and Guaifenesin GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN FD&C RED NO. 40 GELATIN, UNSPECIFIED Light red Oblong 242

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 - 20 Softgel Blister Pack Carton Walgreens NDC 0363-0115-20 Compare to Robitussin® Maximum Strength Cough+Chest Congestion DM active ingredients‡‡ ADULT • NON-DROWSY Wal-Tussin ® DM Max Cough & Chest Congestion DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT MAXIMUM STRENGTH Relieves cough,chest congestion & mucus 12 years & older 20 SOFTGELS Wal-Tussin DM Max.jpg

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 DISTRIBUTED BY: WALGREEN CO. 200 WILMOT ROAD DEERFIELD, IL 60015

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 you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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 if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking 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 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 or comments? 1-888-333-9792

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 condition.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20-25°C (68-77°F). avoid excessive heat above 40°C (104°F).

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 if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema 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 condition. If pregnant or breast-feeding, ask a health professional before use. 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