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
Drug FactsActive Ingredient (in each tablet)Acetaminophen 500 mgPhenylephrine HLC 5 mg
Otc - Purpose
PurposeAcetaminophen ...................Pain reliever/fever reducerPhenylephrine HCl ................Nasal decongestant
Indications & Usage
Uses:Temporarily relieves these symptomsassociated with hay fever or otherrespiratory allergies and the common cold:• headache • sinus congestion and pressure• nasal congestion • minor aches and pains • promotes sinus drainage • temporarily reduces fever
Warnings:Liver warning: This product contains acetaminophen.The maximum daily dose of this product is 6 tablets(3,000 mg acetaminophen) in 24 hours. Severe liverdamage may occur if you take:•more than 4,000 mg of acetaminophen in 24 hours•with other drugs containing acetaminophen•3 or more alcoholic drinks every day while using thisproductAllergy alert: acetaminophen may cause serve skinreactions. Symptoms may include:•skin reddening •blister •rashIf a skin reaction occurs, stop use and seek medicalhelp right away
Otc - Do Not Use
Do not use•with any other drug containing acetaminophen. Ifyou are not sure whether a drug containsacetaminophen, ask a doctor or pharmacist.•if you are now taking a prescription monoamineoxidase inhibitor (MAOIs), or for 2 weeks afterstopping the MAOI drug. If you do not know ifyour prescription drug contains an MAOI, ask adoctor or pharmacist before taking this product.•if you have ever had an allergic reaction to thisproduct or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have:• liver disease• diabetes• heart disease• high blood pressure• thyroid disease• trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug Warfarin
Otc - When Using
When using this product do not exceedrecommended dose
Otc - Stop Use
Stop use and ask a doctor if:• nervousness, dizziness, or sleeplessness occur• pain or nasal congestion gets worse or lastsmore than 7 days• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occurThese could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a healthprofessional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of childrenOverdose warning: in case of overdose, getmedical help or contact a Poison Control Centerright away. (1-800-222-1222) Quick medicalattention is critical for adults as well as for childreneven if you do not notice any signs or symptoms.
Dosage & Administration
Directions:• do not take more than directed (see overdose warning)• adults and children 12 years and over: • take 2 tablet every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 6 tablets in 24 hours• children under 12 years: ask a doctor
Other Safety Information
Other information:read all warnings and directions before use. Keepcarton. Store at 20-25°C (68-77°F) avoid excessiveheat above 40°C (104°F)
Inactive Ingredients:Corn Starch, FD & C Blue #1 Lake, MicrocystallineCellulose, Povidone, Sodium Starch Glycolate,Stearic Acid, USP Purified Water
Aramark100 TABLETS Part # 91933BPER BOXFEDRINPain Reliever/Nasal DecongestantTemporary relief of headaches,sinus pain, nasal and sinus congestion,minor aches, pains, feverMANUFACTURED FOR:AramarkLenexa, KS 66219(913) 269-9611aramarkuniform.comRetain carton for complete product information100 Tablet Box250 Tablet Box2-Tablet Packetres
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