FDA Label for Drx Choice Nighttime Cold And Flu Relief
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH SOFTGEL)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Drx Choice Nighttime Cold And Flu Relief Product Label
The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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
Active Ingredients (In Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
▪ cough due to minor throat & bronchial irritation▪ sore throat▪ headache▪ minor aches & pains▪ fever▪ runny nose & sneezing
Warnings
▪ 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:
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▪ glaucoma▪ cough that occurs with too much phlegm (mucus)▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema▪ trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
▪ taking sedatives or tranquilizers▪ taking the blood thinning drug warfarin
When Using This Product
▪ do not use more than directed▪ excitability may occur, especially in children▪ marked drowsiness may occur▪ avoid alcoholic drinks▪ be careful when driving a motor vehicle or operating machinery▪ alcohol, sedatives, & tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
▪ pain 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
▪ take only as directed▪ do not exceed 8 softgels per 24 hrs
adults & children 12 yrs & over | 2 softgels with water every 6 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 Blue No. 1, D&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
Principal Display Panel
*Compare to the active ingredients in Vicks® NyQuil™ Cold & Flu LiquiCaps™
DRx Choice®
Nighttime
Cold & flu relief
Acetaminophen – Pain Reliever/Fever Reducer
Doxylamine Succinate – Antihistamine
Dextromethorphan HBr – Cough Suppressant
Headache, Fever, Sore Throat, Minor Aches & Pains
Sneezing, Runny Nose, Cough
10 softgels
* Please review the disclaimer below.
