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Vicks formula 44dm cough and chest congestion - Medication Information

Product NDC Code 69423-810
Drug Name

Vicks formula 44dm cough and chest congestion

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/15ml
Guaifenesin 200 mg/15ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 1014005
Application Number M012
Labeler Name The Procter & Gamble Manufacturing Company
Packages
Package NDC Code Description
69423-810-12 354 ml in 1 bottle, plastic (69423-810-12)
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Overdosage of VICKS FORMULA 44DM COUGH and CHEST CONGESTION

Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.
In case of overdose, get medical help or contact a Poison Control Center right away.

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each 15 mL) Dextromethorphan HBr 10 mg Guaifenesin 200 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 • take only as directed • only use the dose cup provided • do not exceed 6 doses per 24 hours adults and children 12 years and over 30 mL every 4 hours children 6 to under 12 years 15 mL every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use
adults and children 12 years and over30 mL every 4 hours
children 6 to under 12 years15 mL every 4 hours
children 4 to under 6 yearsask a doctor
children under 4 yearsdo not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients citric acid, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, 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 temporarily relieves cough due to minor throat and bronchial irritation associated with a cold helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

Purpose

Information about the drug product’s indications for use.
Purpose Cough suppressant Expectorant

Spl product data elements

Usually a list of ingredients in a drug product.
VICKS FORMULA 44DM COUGH and CHEST CONGESTION Dextromethorphan HBr, Guaifenesin SODIUM BENZOATE SUCRALOSE XANTHAN GUM SODIUM CHLORIDE SORBITOL CITRIC ACID MONOHYDRATE FD&C RED NO. 40 PROPYLENE GLYCOL WATER GLYCERIN SACCHARIN SODIUM SODIUM CITRATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN

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 - 354 ml Bottle Label VICKS ® FORMULA 44™ DM COUGH & CHEST CONGESTION Dextromethorphan HBr, Guaifenesin Cough Chest Congestion, Thins & Loosens Mucus Non-Drowsy 12 FL OZ (354 ml) 448

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 TAMPER EVIDENT: Do not use if printed shrinkband is broken or missing. DIST. BY PROCTER & GAMBLE, CINCINNATI OH 45202

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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) a sodium-restricted diet

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-362-1683

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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 • each 15 mL contains: sodium 45 mg • store at no greater than 25°C

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.

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