Desresfriol-DX Softgels ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE OPMX LLC. FDA Approved Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each Softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant
Inactive Ingredients
Inactive ingredients FD&C Red No. 40 FD&C Yellow No. 6 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol special 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 Bronchial Irritation Sore Throat Headache Minor Aches Pains Fever
Pill Appearance
Shape: oval Color: red Imprint: AP01

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0810053180723
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

PRINCIPAL DISPLAY PANEL NDC 69729-121-10 Desresfriol-DX Acetaminophen, Dextromethorphan, Phenylephrine Flu&Cough Gripe y Tos Dolor de cuerpo/Body Aches Fiebre/Fever Dolor de Garganta/Sore Throat Congestion Nasal/Nasal Congestion Tos/Cough 10 Cápsulas Blandas de Gel/Softgels Desrefriol DayTime 10 Softgel

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 69729-121-10 Desresfriol-DX Acetaminophen, Dextromethorphan, Phenylephrine Flu&Cough Gripe y Tos Dolor de cuerpo/Body Aches Fiebre/Fever Dolor de Garganta/Sore Throat Congestion Nasal/Nasal Congestion Tos/Cough 10 Cápsulas Blandas de Gel/Softgels Desrefriol DayTime 10 Softgel

Overview

Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever

Indications & Usage

Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever

Dosage & Administration

Directions Take only as directed. Do not exceed 4 doses per 24 hrs. Adults & children 12 yrs & over 2 softgels 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 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert Acetaminophen may cause severe skin reactions. Symtoms 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. 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. Ask a doctor before use if you have Liver disease Heart disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask a doctor or pharmacist before use if you are: Taking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if You get nervouz, dizzy or sleepless. Symptoms get worse or last more than 5 days (children) or 7 days (adults). Fever gets worse or lasts more than 3 days. Redness or swelling is present. New symtoms 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. If pregnant or breast-feeding, ask a health professional before use. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well for children even if you do not notice any signs or symptoms.
Purpose

Active ingredients (in each Softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant

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.

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 nervouz, dizzy or sleepless. Symptoms get worse or last more than 5 days (children) or 7 days (adults). Fever gets worse or lasts more than 3 days. Redness or swelling is present. New symtoms 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.

Storage & Handling

Other information Store at room temperature

Questions

Questions? Call to free 619-600-5632 Monday throughFriday 9AM - 5PM EST


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