AGRIFEN ACETAMINOPHEN DEXTOMETHORPHAN 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 and pains Fever
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Active ingredients (in each Softgel) Purposes Acetaminophen 325 mg Pain reliever/Fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5mg Nasal descongestant Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches and pains Fever Uses Pain reliever/Fever reducer Cough suppressant Nasal descongestant
Inactive Ingredients
Inactive ingredients FD&C Red No.40 FD&C Yellow No. 6 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol 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 And Pains Fever
Pill Appearance
Shape: oval Color: red

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0810053181645
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

NDC 69729-802-10 AGRIFEN Acetaminophen 325 mg Dextomethorphan HBr 10 mg Phenylephrine HCl 5 mg Dolor de Cabeza Headache Congestión Nasal Nassal Congestion Ojos llorosos Itchi, Watery eyes Escurrimiento Nasal y Estornudos Runny Nose & Sneezing 10 Soft Gels Exclusively distributes by: OPMX Chula Vista, CA 91910 Phine: 619-600-5632 TAMPER EVIDENT: Do not use if package is opened or if blister unit is torn, broken or shows any sign of tampering agrifen 2

Package Descriptions
  • NDC 69729-802-10 AGRIFEN Acetaminophen 325 mg Dextomethorphan HBr 10 mg Phenylephrine HCl 5 mg Dolor de Cabeza Headache Congestión Nasal Nassal Congestion Ojos llorosos Itchi, Watery eyes Escurrimiento Nasal y Estornudos Runny Nose & Sneezing 10 Soft Gels Exclusively distributes by: OPMX Chula Vista, CA 91910 Phine: 619-600-5632 TAMPER EVIDENT: Do not use if package is opened or if blister unit is torn, broken or shows any sign of tampering agrifen 2

Overview

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

Dosage & Administration

Directions Take only as directed. Do not exceed 4 doses per 24 hours. 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. Symptoms may include: Skin reddening Blisters Rash If a skin reactions occurs, stop use and seek medical help right away Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompained 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 Hear disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland Cough that occurs with too mcuh plegm (mucus) Persistent or chronic cough 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 nervous, 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 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 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 as for children even if you dot notice any signs or symptoms.
Purpose

Uses Pain reliever/Fever reducer Cough suppressant Nasal descongestant

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 nervous, 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 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

Storage & Handling

Other information Store at room temperature.

Questions

Questions? Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST


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