Nite-Time COLD/FLU Medicine ACETAMINOPHEN APTAPHARMA INC. FDA Approved Uses Uses temporarily relieves cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever
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Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Drug Facts Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
Inactive Ingredients
Inactive Ingredients Inactive ingredients: citric acid D and C yellow No. 10 FD and C Green No. 3 FD and C Yellow No. 6 flavor glycerin polyethylene glycol propylene glycol purified water saccharin sodium sodium benzoate sodium citrate sucrose
Strengths
30 ml 650 mg 30 mg 12.5 mg
Quantities
354 ml
Treats Conditions
Uses Uses Temporarily Relieves Cold Flu Symptoms Sore Throat Minor Aches And Pain Runny Nose And Sneezing Cough Due To Minor Sore Throat And Bronchial Irritation Headache Fever

Identifiers & Packaging

Container Type UNKNOWN
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

Package Label - Night Time Cold & Flu Relief NDC 76281-501-28 AP SAFE *COMPARE TO the active ingredients in VICKS ® NYQUIL ® Night Time Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Doxylamine Succinate – Antihistamine Multi-Symptom Cold & Flu Relief Original Flavor 12 FL OZ (354 mL) DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN Failure to follow these warnings could result in serious consequences *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil®. Manufactured by: AptaPharma Inc., 1533 Union Ave., Pennsauken, NJ 08110 12 OZ 6 OZ res 501-28 12oz Botl 501-25 6 OZ

Package Descriptions
  • Package Label - Night Time Cold & Flu Relief NDC 76281-501-28 AP SAFE *COMPARE TO the active ingredients in VICKS ® NYQUIL ® Night Time Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Doxylamine Succinate – Antihistamine Multi-Symptom Cold & Flu Relief Original Flavor 12 FL OZ (354 mL) DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN Failure to follow these warnings could result in serious consequences *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil®. Manufactured by: AptaPharma Inc., 1533 Union Ave., Pennsauken, NJ 08110 12 OZ 6 OZ res 501-28 12oz Botl 501-25 6 OZ

Overview

Uses Uses temporarily relieves cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever

Indications & Usage

Uses Uses temporarily relieves cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever

Dosage & Administration

Directions Directions take only as recommended-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours adults and children 12 years and over 30 mL (2TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product ● with other drugs containing acetaminophen ● 3 or more alcoholic drinks everyday while using this product. 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.
Purpose

Purpose Purpose Pain reliever/fever reducer Cough suppressant Antihistamine

Do Not Use

Do Not Use 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 to make a child sleepy

When Using

When Using This Product When using this product do not use more than directed avoid alcoholic drinks excitability may occur, especially in children marked drowsiness may occur be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use & Ask a Doctor

Stop Use And Ask A Doctor Stop use and ask a doctor if redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts

Keep Out of Reach of Children

Keep Out Of Reach Of Children Keep out of reach of children.


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