Nite Time Cold and Flu Relief NITE TIME COLD AND FLU RELIEF TOPCO ASSOCIATES, LLC FDA Approved Use(s) temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient(s) Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg
Inactive Ingredients
Inactive ingredients D&C yellow #10 FD&C blue #1 gelatin glycerin polyethylene glycol povidone propylene glycol purified water sorbitol sorbitan solution white edible ink
Strengths
325 mg 15 mg 6.25 mg
Treats Conditions
Use S 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: capsule Color: green Imprint: PC10

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0036800367357
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

Principal Display Panel Nitetime Cold and Flu Nitetime Cold and Flu

Package Descriptions
  • Principal Display Panel Nitetime Cold and Flu Nitetime Cold and Flu

Overview

Use(s) 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

Use(s) 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 hours Adults and children 12 years and over: 2 softgels with water every 6 hours Children 4 to under 12 years of age: ask a doctor Children under 4 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, occurs with or is 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. • to make a child sleep Ask a doctor before use if • 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 a doctor or pharmacist before use if • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • do not use more than directed • 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 breastfeeding, ask a health professional before use. 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 as well as for children, even if you do not notice any signs or symptoms.
Purpose

Purpose Pain reliever/fever reducer Cough suppressant 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. • to make a child sleep

When Using

When using this product • do not use more than directed • 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 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 as well as for children, even if you do not notice any signs or symptoms.

Questions

Questions/Comments Call 1-888-952-0050 Monday through Friday 9AM - 5PM


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