Active Ingredient (In Each 10 Ml)
Dextromethorphan HBr, USP 30 mg
Drx Choice Long Acting Cough Liquid
FDA Label NDC 68163-742
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals for the product Drx Choice Long Acting Cough (NDC 68163-742). 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
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
▪ 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
▪ each 10 ml contains: sodium 3 mg▪ store at room temperature
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?
1-866-467-2748
Principal Display Panel
*Compare to the active ingredient in Adult Robitussin® Long-Acting Cough*
NDC 68163-742-04
DRx Choice
long-acting
cough
Dextromethorphan HBr (Cough Suppressant)
Relieves: Cough
8 HOURS RELIEF
No Added Alcohol
Sugar-Free
For Ages 12 & Over
4 FL OZ (118mL)
*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Adult Robitussin® Long-Acting Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.
IMPORTANT: Keep this carton for future reference for full labelling.
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick,
NJ 08816
* Please review the disclaimer below.
