Active Ingredients For Daytime (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Drx Choice Kit
FDA Label NDC 68163-064
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 Inc for the product Drx Choice (NDC 68163-064). 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 for daytime (in each softgel), active ingredients for nighttime (in each softgel), purposes (daytime), purposes (nighttime), uses, warnings, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients For Nighttime (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Purposes (Daytime)
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant
Purposes (Nighttime)
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Uses
▪ temporarily relieves common cold or flu symptoms:▪ Nasal congestion (Daytime only)▪ headache▪ minor aches and pains▪ cough due to minor throat and bronchial irritation▪ sore throat▪ fever▪ runny nose & sneezing (Nighttime only)
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
▪ more than 8 softgels in 24 hours, which is the maximum daily amount for this product▪ with other drugs containing acetaminophen▪ 3 or more alcoholic drinks every day while using this product▪ skin reddening▪ blisters▪ rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.
Do Not Use
▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.▪ 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
▪ liver disease▪ Heart disease (Daytime only)▪ High blood pressure (Daytime only)▪ Thyroid disease (Daytime only)▪ Diabetes (Daytime only)▪ Trouble urinating due to enlarged prostate gland▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)▪ cough that occurs with too much phlegm (mucus)▪ glaucoma (Nighttime only)▪ persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
Ask A Doctor Or Pharmacist Before Use If You Are
▪ taking sedatives or tranquilizers (Nighttime Only)▪ taking the blood thinning drug warfarin
When Using This Product
▪ do not use more than directed▪ excitability may occur, especially in children (Nighttime only)▪ marked drowsiness may occur (Nighttime only)▪ avoid alcoholic drinks (Nighttime only)▪ alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)▪ be careful when driving a motor vehicle or operating machinery (Nighttime only)
Stop Use And Ask A Doctor If
▪ you get nervous, dizzy or sleepless (Daytime Only)▪ pain or cough gets worse or lasts more than 7 days (Nighttime Only)▪ pain, nasal congestion or cough gets worse or lasts more than 7 days (Daytime only)▪ fever gets worse or lasts more than 3 days▪ redness or swelling is present▪ new symptoms occur▪ cough comes back or occurs with rash or headache that lasts.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
▪ take only as directed▪ Do not exceed 8 softgels per 24 hrs
2 softgels with water every 6 hrs | ||
Ask doctor | ||
children under 4 years | Do not use |
Other Information
▪ store at room temperature.
Inactive Ingredients
Daytime: -FD&C Red No 40, FD&C Yellow No 6, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide Nighttime: - FD&C Blue No 1, FD&C Yellow No 10, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide
Questions Or Comments?
1-866-467-2748
Other Safety Information
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER-EVIDENT: This Package is safety-sealed & Child resistant. Use only if blisters are intact. If difficult to open, use scissors.
Principal Display Panel
*Compare to the active ingredients in Vicks® DayQuil™ & NyQuil™ Cold & Flu LiquiCaps™
NDC 68163-064-12
DRx Choice®
Daytime
Cold & flu relief
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl – Nasal decongestant
Headache, Fever, Sore Throat, Minor Aches & Pains, Nasal Congestion, Sinus Pressure & Cough
6 Softgels
Nighttime
Cold & flu relief
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr -Cough Suppressant
Doxylamine Succinate - Antihistamine
Headache, Fever, Sore throat, Minor Aches & Pains, Sneezing, Runny nose, Cough
6 softgels
12 Total Softgels
Distributed by:
Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil™ & NyQuil™ Cold & Flu LiquiCaps™
Drx Choice Daytime & Nighhtime Cold & Flu Relief 12 Softgels (Image 01)
* Please review the disclaimer below.
