Nighttime Cold/Flu Relief Softgels (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) Dailymed
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DRUG FACTS
Otc - Active Ingredient Section
Active ingredients (in each softgel)Acetaminophen               325 mgDextromethorphan HBr     15 mg Doxylamine Succinate    6.25 mg
Otc - Purpose Section
Purpose Acetaminophen …………….….Pain reliever/fever reducerDextromethorphan HBr .....Cough suppressantDoxylamine succinate ……...Antihistamine
Indications & Usage Section
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 Section
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 product Allergy Alert: Acetaminophen may cause severe skinreactions. Symptoms may include:• skin reddening • bulers • 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 Section
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 Section
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 Section
Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers• taking the blood thinning drug warfarin
Otc - When Using Section
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 Section
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 Section
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children Section
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 Section
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 Ingredient Section
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 Section
Questions? Call weekdays from 9:30 am to 4:30 pm EST. 1-877-798-5944
Product Label
Premier Value®
*COMPARE TO THE ACTIVE INGREDIENTSIN VICKS® NYQUIL® COLD & FLUNIGHTTIME RELIEF LIQUICAPS®
Nighttime
COLD/FLU RELIEF Acetaminophen/ Dextromethorphan HBr/Doxylamine Succinate
• Aches, Fever & Sore Throat• Sneezing, Runny Nose• Cough
16 Softgels
  INDEPENDENTLY TESTED               PVSATISFACTION GUARANTEED
Distributed by: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087
  INDEPENDENTLY TESTED                PVSATISFACTION GUARANTEED
If 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 warnings could result in serious consequences.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER BOX FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
BX-096
  5 098188 1/20
16 Softgels Label
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24 SofTgels Label
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