Leader Vapor Ice Cold and Flu ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE CARDINAL HEALTH 110, LLC. DBA LEADER FDA Approved Uses • temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide croscarmellose sodium crospovidone FD&C yellow #6 aluminum lake flavor magnesium stearate microcrystalline cellulose polyethylene glycol 3350 polyvinyl alcohol povidone pregelatinized starch propylene glycol stearic acid sucralose talc titanium dioxide
Strengths
325 mg 10 mg
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Cough Due To Minor Throat And Bronchial Irritation Sore Throat Headache Minor Aches And Pains Fever
Pill Appearance
Shape: oval Color: orange Imprint: 71P

Identifiers & Packaging

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

Package/Label Principal Display Panel New Formula LEADER ™ Vapor Ice ® Cold & Flu Acetaminophen, 325 mg Dextromethorphan HBr, 10 mg Pain Reliever / Fever Reducer | Cough Suppressant Headache, Fever, Sore Throat Minor Aches & Pains, Cough Non-Drowsy Actual Size COMPARE TO VICKS® DAYQUIL® VAPOCOOL® active ingredients 24 CAPLETS 100% Money Back Guarantee Vapor Ice Cold and Flu Image 1 Vapor Ice Cold and Flu Image 2

Package Descriptions
  • Package/Label Principal Display Panel New Formula LEADER ™ Vapor Ice ® Cold & Flu Acetaminophen, 325 mg Dextromethorphan HBr, 10 mg Pain Reliever / Fever Reducer | Cough Suppressant Headache, Fever, Sore Throat Minor Aches & Pains, Cough Non-Drowsy Actual Size COMPARE TO VICKS® DAYQUIL® VAPOCOOL® active ingredients 24 CAPLETS 100% Money Back Guarantee Vapor Ice Cold and Flu Image 1 Vapor Ice Cold and Flu Image 2

Overview

Uses • temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever

Indications & Usage

Uses • temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever

Dosage & Administration

Directions • take only as directed - see overdose warning • do not exceed 8 caplets per 24 hrs adults & children 12 yrs & over 2 caplets with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs 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 • liver disease • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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

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

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Questions

Questions or comments? 1-800-719-9260


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