Topcare DayTime Cold and Flu Relief ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE TOPCO ASSOCIATES LLC 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
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid FD&C blue no. 1 FD&C red no. 40 flavor glycerin propylene glycol purified water saccharin sodium sodium benzoate sodium citrate sorbitol solution sucralose xanthan gum
Strengths
15 ml 325 mg 10 mg
Quantities
355 ml
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

Identifiers & Packaging

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

Package/Label Principal Display Panel TopCare ® health COMPARE TO VICKS® DAYQUIL® ACTIVE INGREDIENTS MULTI-SYMPTOM RELIEF DayTime Cold & Flu Relief PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr ● Headache, Fever, Sore Throat, Minor Aches & Pains ● Cough Alcohol Free Antihistamine Free Non-Drowsy 12 FL OZ (355 mL) ELDERBERRY FLAVORED DayTime Cold & Flu Relief Label

Package Descriptions
  • Package/Label Principal Display Panel TopCare ® health COMPARE TO VICKS® DAYQUIL® ACTIVE INGREDIENTS MULTI-SYMPTOM RELIEF DayTime Cold & Flu Relief PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr ● Headache, Fever, Sore Throat, Minor Aches & Pains ● Cough Alcohol Free Antihistamine Free Non-Drowsy 12 FL OZ (355 mL) ELDERBERRY FLAVORED DayTime Cold & Flu Relief Label

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 • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 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 • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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 5 days (children) or 7 days (adults) • 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 5 days (children) or 7 days (adults) • 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? 1-888-423-0139


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