Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Premier Value Solution
FDA Label NDC 68016-744
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance Llc for the product Premier Value (NDC 68016-744). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each 20 ml), purposes, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Cough suppressant
Expectorant
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
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 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.
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 (1-800-222-1222).
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 |
Other Information
▪ store at room temperature. Do not refrigerate.▪ Alcohol-free
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
Questions Or Comments?
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Package/Label Principal Display Panel
Compare to the active ingredients of Robitussin® Sugar Free Cough + Congestion DM
NDC# 68016-744-04
Premier Value®
Sugar Free
Tussin DM
Cough Suppressant
Dextromethorphan HBr
Expectorant
Guaifenesin
- Relieves Chest Congestion
- Controls cough and mucus
Specially Formulated for DIABETICS
Non-Drowsy
For Ages 12 & Over
4 FL OZ (118 mL)
IMPORTANT: Keep this carton for future reference on full labeling. |
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® Sugar Free Cough + Congestion DM.
Premier Value Sugar Free Tussin Dm (2b7 45 Tussin Dm Max)
* Please review the disclaimer below.
