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Drug Facts
TAMPER EVIDENT: This package is safety-sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.
Distributed by: Raritan Pharmaceuticals
8 Joanna Court
East Brunswick, NJ 08816
Drx Choice Capsule, Liquid Filled
FDA Label NDC 68163-061
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 68163-061). 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 other, active ingredients (in each softgel), purpose, uses, liver warning:, allergy alert:, sore throat warning:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
temporarily relieves common cold/flu symptoms:
▪ nasal congestion▪ cough due to minor throat & bronchial irritation▪ sore throat▪ headache▪ minor aches & pains▪ fever
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
Allergy Alert:
Acetaminophen may cause severe skin reactions.
Symptoms may include:
▪ skin reddening▪ blisters▪ Rash
If a skin reaction occurs, stop use and seek medical help right away.
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▪ high blood pressure▪ thyroid disease▪ diabetes▪ trouble urinating due to enlarged prostate gland▪ cough that occurs with too much phlegm (mucus)▪ persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product,
do not use more than directed.
Stop Use And Ask A Doctor If
▪ you get nervous, dizzy or sleepless▪ pain, nasal congestion or cough gets worse or lasts more than 7 days▪ 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. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 & 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
adults & children 12 yrs & over | 2 softgels with water every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
Other Information
▪ store at room temperature
Inactive Ingredients
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide
Questions Or Comments?
1-866-467-2748
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*Compare to the active ingredients in Vicks® DayQuil™ Cold & Flu LiquiCaps™
NDC 68163-061-10
DRx Choice®
Daytime
Cold & flu relief
Acetaminophen – Pain Reliever/Fever Reducer
Phenylephrine HCl – Nasal decongestion
Dextromethorphan HBr – Cough Suppressant
Headache, Fever, Sore Throat, Minor Aches & Pains
Nasal Congestion, Sinus Pressure & Cough
10 softgels
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
*This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® DayQuil™ Cold & Flu LiquiCaps™
Dtr Daytime Cold & Flu Relief 10 Softgels (994.jpg.jpg)
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