Night Time Cold and Flu ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE PHENYLEPHRINE HYDROCHLORIDE RETAIL BUSINESS SERVICES, LLC FDA Approved Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredient D&C yellow #10 FD&C blue #1 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol sorbitan solution and white edible ink
Strengths
325 mg 10 mg 6.25 mg 5 mg
Treats Conditions
Uses Temporarily Relieves These Common Cold And Flu Symptoms Cough Nasal Congestion Minor Aches And Pains Sore Throat Headache Runny Nose Sneezing Temporarily Reduces Fever Controls Cough To Help You Get To Sleep
Pill Appearance
Shape: capsule Color: green Imprint: PC22

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 04JA59TNSJ
Packaging

PRINCIPAL DISPLAY PANEL CareOne Nighttime Cold & Flu 16ct compare to Mucinex Fast-Max Night Time Cold & Flu active ingredients NDC 72476-998-14 Principle Display Panel Drug Facts

Package Descriptions
  • PRINCIPAL DISPLAY PANEL CareOne Nighttime Cold & Flu 16ct compare to Mucinex Fast-Max Night Time Cold & Flu active ingredients NDC 72476-998-14 Principle Display Panel Drug Facts

Overview

Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep

Dosage & Administration

Directions do not take more than directed (see Overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and older: take 2 softgels every 4 hours children under 12 years of age: 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 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, persists 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 thyroid disease glaucoma trouble urinating due to an enlarged prostate gland breathing problems such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) 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 taking sedatives or tranquilizers When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. 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

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine 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 excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

Stop Use & Ask a Doctor

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

Storage & Handling

Other information store between 15-30°C (59-86°F) avoid excessive heat

Questions

Questions or Comments? Call toll free: 1-866-322-2439


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