Active ingredient A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each 20 mL) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 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 • shake well before using • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 20 mL every 4 hours children under 12 years do not use
|adults and children 12 years and over||20 mL every 4 hours|
|children under 12 years||do not use|
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, FD&C Red No. 40, flavor, menthol, microcrystalline cellulose, povidone, propylene glycol, purified water, potassium citrate, sodium benzoate, 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 • 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.
Purposes Cough suppressant Expectorant
Spl product data elements Usually a list of ingredients in a drug product.
Premier Value Maximum Strength Dextromethorphan HBr, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED EDETATE DISODIUM FD&C RED NO. 40 MENTHOL, UNSPECIFIED FORM MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER POTASSIUM CITRATE 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.
Package/Label Principal Display Panel *Compare to the active ingredients of Robitussin® Cough + Chest Congestion DM NDC# 68016-740-04 Maximum Strength for MUSCUS RELIEF Tussin DM Max Cough Suppressant, Dextromethorphan HBr Expectorant, Guaifenesin • Relieves Chest Congestion • Controls cough and mucus Non-Drowsy For Ages 12 & Over 4 FL OZ (118 mL) Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 *This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin ® Cough + Congestion DM. Premier Value Max Strength Dextrometorphan HBr, Guaifenesin
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 (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 cough lasts for more than 7 days, comes back, 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 20 mL contains: sodium 7 mg • store at room temperature. Do not refrigerate. • Alcohol-free
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.