Active Ingredient (In Each 10 Ml)
Dextromethorphan HBr, USP 30 mg
Premier Value Tussin Cough Liquid
FDA Label NDC 68016-742
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Premier Value Tussin Cough (NDC 68016-742). 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 ingredient (in each 10 ml), purpose, 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
Purpose
Cough suppressant
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, 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 at (1-800-222-1222).
Directions
- shake well before using
- do not take more than 4 doses in a 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 | 10 mL every 6 to 8 hours |
children under 12 years | do not use |
Other Information
- store between 20-25°C (68-77°F)
- Do not refrigerate
- Alcohol-free
Inactive Ingredients
anhydrous citric acid, disodium edetate, FD&C red 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
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Principal Display Panel
Premier Value®
NDC# 68016-742-04
*Compare to active ingredient in Robitussin® Long-Acting Cough*
Tussin Cough Long-acting
Cough Suppressant
Dextromethorphan HBr
Controls Coughs
8 Hour Relief
Non-Drowsy
For Ages 12 & Over
4 FL OZ (118mL)
*This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributors of Robitussin® Lingering Cold Long-Acting Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.
PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
* Please review the disclaimer below.
