Nitecin ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE OPMX LLC FDA Approved Uses Temporarily relieves common cold/flu symptoms: Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever Runny nose & sneezing
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each Softgels) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine
Inactive Ingredients
Inactive ingredients D&C Yellow No. 10 FD&C Blue No. 1 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol special titanium dioxide
Strengths
325 mg 15 mg 6.25 mg
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Cough Due To Minor Throat Bronchial Irritation Sore Throat Headache Minor Aches Pains Fever Runny Nose Sneezing
Pill Appearance
Shape: oval Color: green Imprint: AP02

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

PRINCIPAL DISPLAY PANEL NDC 69729-054-10 Cough & Flu/ Tos y Gripe Nitecin Night-ttmeRelief Multi-Symptom Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Headache/ Dolor de cabeza Fever/ Fiebre Sore Throat/ Dolor de Garganta Sneezing/ Estornudos Runny Nose/ Secreción Nasal Cough/ Tos 10 Softgels/ 10 Cápsulas Blandas de Gel Nitecin

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 69729-054-10 Cough & Flu/ Tos y Gripe Nitecin Night-ttmeRelief Multi-Symptom Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate Headache/ Dolor de cabeza Fever/ Fiebre Sore Throat/ Dolor de Garganta Sneezing/ Estornudos Runny Nose/ Secreción Nasal Cough/ Tos 10 Softgels/ 10 Cápsulas Blandas de Gel Nitecin

Overview

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

Indications & Usage

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

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 6 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 reaction occurs, stop use and seek medical help right away Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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 glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland Ask doctor or pharmacist before use if you are Taking sedatives or tranquilizers Taking the blood thinning drug warfarin When using this product Excitability may occur, especially in children Marked drowsiness may occur Avoid Alcoholic drinks Be careful when driving a motor vehicle or operating machinery Alcohol, sedatives, & tranquilizers may increase drowsiness Stop use and ask a doctor if Pain 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. 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. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Purpose

Active ingredients (in each Softgels) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine

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 Excitability may occur, especially in children Marked drowsiness may occur Avoid Alcoholic drinks Be careful when driving a motor vehicle or operating machinery Alcohol, sedatives, & tranquilizers may increase drowsiness

Stop Use & Ask a Doctor

Stop use and ask a doctor if Pain 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.

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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