DAYTIME COLD AND FLU RELIEF ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE ADVANCED RX LLC FDA Approved Uses Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever sore throat
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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 Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients FD&C Red No. 40 FD&C Yellow No. 6 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol methyl paraben propyl paraben titanium dioxide
Strengths
325 mg 10 mg 5 mg
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Nasal Congestion Cough Due To Minor Throat And Bronchial Irritation Sore Throat Headache Minor Aches And Pains Fever Sore Throat
Pill Appearance
Shape: oval Color: orange Imprint: SN2

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

PRINCIPAL DISPLAY PANEL NDC 80513-303-50 Compare to the active ingredients in Vicks ® DayQuil ® Cold & Flu LiquiCaps ® 50 Softgels NON-DROWSY DAYTIME COLD & FLU RELIFE Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr Pain Reliever Fever Reducer Cough Suppressant Nasal Decongestant label

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 80513-303-50 Compare to the active ingredients in Vicks ® DayQuil ® Cold & Flu LiquiCaps ® 50 Softgels NON-DROWSY DAYTIME COLD & FLU RELIFE Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr Pain Reliever Fever Reducer Cough Suppressant Nasal Decongestant label

Overview

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

Indications & Usage

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

Dosage & Administration

Directions take only as directed do not exceed 4 doses per 24 hours adults and children 12 years and over take 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Purpose

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

Do Not Use

Do not use with any other product containing acetaminophen (prescription or non-prescription). 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, do not use more than directed.

Stop Use & Ask a Doctor

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information store at room temperature. DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Questions

Questions? 1-800-630-8895


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