Ultra Concentrated Daytime COLD AND FLU ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE PURACAP PHARMACEUTICAL LLC FDA Approved Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat 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 Softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg
Inactive Ingredients
Inactive ingredients FD&C red #40 FD&C yellow #6 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol special white edible ink
Strengths
325 mg 10 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold Or Flu Minor Aches And Pains Headache Cough Sore Throat Temporarily Reduces Fever
Pill Appearance
Shape: capsule Color: orange Imprint: P9

Identifiers & Packaging

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

PRINCIPAL DISPLAY PANEL Ultra Concentrated Daytime COLD AND FLU Capsules 8 SOFTGELS NDC 51013-667-01 * Compare to the active ingredients in Vicks ® DayQuil® Cold&Flu LiquiCaps® carton label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Ultra Concentrated Daytime COLD AND FLU Capsules 8 SOFTGELS NDC 51013-667-01 * Compare to the active ingredients in Vicks ® DayQuil® Cold&Flu LiquiCaps® carton label

Overview

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat temporarily reduces fever

Indications & Usage

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat temporarily reduces fever

Dosage & Administration

Directions do not take more than the recommended dose adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 8 softgels in 24 hours or as directed by a doctor 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 10 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day 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. 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. 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 in children under 12 years of age Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland 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 When using this product do not exceed recommended dosage Stop use and ask a doctor if pain, 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. nervousness, dizziness, or sleeplessness occurs 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. 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 in children under 12 years of age

When Using

When using this product do not exceed recommended dosage

Stop Use & Ask a Doctor

Stop use and ask a doctor if pain, 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. nervousness, dizziness, or sleeplessness occurs

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. Quick 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 Store at room temperature. Avoid excessive heat.

Questions

Questions or comments? Call toll free: 1-855-215-8180


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