The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients (in each softgel)Acetaminophen 325 mgDextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg
Otc - Purpose
PurposeAcetaminophen …………….….Pain reliever/fever reducerDextromethorphan HBr .....Cough suppressantDoxylamine succinate ……...Antihistamine
Indications & Usage
Uses temporarily relieves common cold/flu symptoms:• cough due to minor throat and bronchial irritation• sore throat • headache • minor aches & pains • fever• runny nose and sneezing
Warnings Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take:• more than 4 doses, in 24 hrs, which is the maximum daily amountfor this product with other drugs containing acetaminophen • 3or more alcoholic drinks daily while using this productAllergy Alert: Acetaminophen may cause severe skinreactions. Symptoms may include:• skin reddening • blisters • rashIf a skin reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, lasts for more than 2days, occurs with or is followed by fever, headache, rash,nausea, or vomiting, consult a doctor promptly.
Otc - Do Not Use
Do not use • with any other drug containing acetaminophen(prescription or nonprescription). If you are not sure whether a drugcontains acetaminophen, ask a doctor or pharmacist• if you are now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotionalconditions, or Parkinson's disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your prescription drug contains anMAOI, ask a doctor or pharmacist before taking this product.• to make a child sleepy
Otc - Ask Doctor
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 occurswith smoking, asthma, chronic bronchitis or emphysema• trouble urinating due to enlarged prostate gland.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are• taking sedatives or tranquilizers• taking the blood thinning drug warfarin
Otc - When Using
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
Otc - Stop Use
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.In case of accidental overdose, get medical help or contacta Poison Control Center right away. Quick medical attention iscritical for adults as well as children, even if you do not noticeany signs or symptoms.
Dosage & Administration
Directions• take only as directed (see Warnings)• do not exceed 4 doses per 24 hrs adults & children 12 years & over 2 softgel with water every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use• when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Other Safety Information
Other information• Store at room temperature 20-25oC (68-77oF)• avoid excessive heat
Inactive ingredients D&C yellow # 10, FD&C Blue # 1,Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide
Otc - Questions
Questions? Call weekdays from 9:30 am to 4:30 pm EST.1-877-798-5944
PremierValue®*COMPARE TO THE ACTIVE INGREDIENTSIN VICKS® NYQUIL® COLD & FLUNIGHTTIME RELIEF LIQUICAPS®NighttimeCOLD/FLU RELIEFAcetaminophen/ Dextromethorphan HBr/Doxylamine Succinate• Aches, Fever & Sore Throat• Sneezing, Runny Nose• Cough16 Softgels INDEPENDENTLY TESTED PVSATISFACTION GUARANTEEDDistributed by:Pharmacy Value Alliance, LLC407 East Lancaster Avenue,Wayne, PA 19087 INDEPENDENTLY TESTED PVSATISFACTION GUARANTEEDIf for any reason you are not completely satisfied withthis product, please return it to the storewhere purchased for a full refund.Failure to follow these warningscould result in serious consequences.TAMPER EVIDENT: DO NOT USE IFCARTON IS OPEN OR BLISTERUNIT IS TORN, BROKEN OR SHOWSANY SIGNS OF TAMPERING.KEEP OUTER BOX FOR COMPLETEWARNINGS AND PRODUCTINFORMATION.BX-096 5098188 1/2016 Softgels Label24 SofTgels Labelres
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