Cold and Flu Nighttime ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE CARDINAL HEALTH 110, LLC. DBA LEADER FDA Approved Uses temporarily relieves common cold and flu symptoms: headache minor aches and pains sore throat runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine succinate 12.5 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid FD&C blue #1 FD&C red #40 flavor glycerin high fructose corn syrup polyethylene glycol 400 propylene glycol purified water sodium benzoate sodium chloride sodium citrate dihydrate sodium saccharin sucralose
Strengths
30 ml 650 mg 30 mg 12.5 mg
Quantities
355 ml
Treats Conditions
Uses Temporarily Relieves Common Cold And Flu Symptoms Headache Minor Aches And Pains Sore Throat Runny Nose And Sneezing Cough Due To Minor Throat And Bronchial Irritation Temporarily Reduces Fever
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0096295143300
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

Principal display panel LEADER™ NDC 70000-0673-1 Nighttime Cold & Flu Acetaminophen Dextromethorphan HBr Doxylamine Succinate Pain Reliever / Fever Reducer Cough Suppressant Antihistamine Cherry Flavor Relief of: • Headache • Fever • Sore Throat • Minor Aches & Pains • Sneezing • Runny Nose • Cough For Ages 12 & Over COMPARE TO VICKS® NYQUIL® COLD & FLU active ingredients* 100% Money Back Guarantee 12 FL OZ (355 mL) TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® NyQuil® Cold & Flu. 50844 ORG032301302 DIST. BY CAH DUBLIN, OH 43017 www.myleader.com 1-800-200-6313 100% Money Back Guarantee Return to place of purchase. Leader 44-013 Leader 44-013

Package Descriptions
  • Principal display panel LEADER™ NDC 70000-0673-1 Nighttime Cold & Flu Acetaminophen Dextromethorphan HBr Doxylamine Succinate Pain Reliever / Fever Reducer Cough Suppressant Antihistamine Cherry Flavor Relief of: • Headache • Fever • Sore Throat • Minor Aches & Pains • Sneezing • Runny Nose • Cough For Ages 12 & Over COMPARE TO VICKS® NYQUIL® COLD & FLU active ingredients* 100% Money Back Guarantee 12 FL OZ (355 mL) TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® NyQuil® Cold & Flu. 50844 ORG032301302 DIST. BY CAH DUBLIN, OH 43017 www.myleader.com 1-800-200-6313 100% Money Back Guarantee Return to place of purchase. Leader 44-013 Leader 44-013

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed do not exceed 4 doses per 24 hours mL = milliliter only use the dose cup provided adults and children 12 years and over: 30 mL every 6 hours children under 12 years: do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage 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 this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland liver disease glaucoma a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product marked drowsiness may occur excitability may occur, especially in children avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days redness or swelling is present fever gets worse or lasts more than 3 days new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine

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. if you have ever had an allergic reaction to this product or any of its ingredients

When Using

When using this product marked drowsiness may occur excitability may occur, especially in children avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days redness or swelling is present fever gets worse or lasts more than 3 days new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information each 30 mL contains: sodium 13 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Questions

Questions or comments? 1-800-426-9391


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