NIGHTTIME COLD AND FLU ACETAMINOPHEN DOXYLAMINE SUCCINATE AND DEXTROMETHORPHAN HBR BI-MART FDA Approved Uses temporarily relieves common cold/flu symptoms: • sore throat • minor aches and pains • runny nose and sneezing • headache • fever • cough due to minor throat and bronchial irritation.
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
Inactive Ingredients
Inactive ingredients citric acid D&C Yellow #10 FD&C Green #3 FD&C Yellow #6 flavor glycerin menthol propylene glycol purified water sodium benzoate sorbitol solution sucralose xanthan gum.
Strengths
30 ml 650 mg 30 mg 12.5 mg
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Sore Throat Minor Aches And Pains Runny Nose And Sneezing Headache Fever Cough Due To Minor Throat And Bronchial Irritation
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0071357912452
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2
Packaging

label

Package Descriptions
  • label

Overview

Uses temporarily relieves common cold/flu symptoms: • sore throat • minor aches and pains • runny nose and sneezing • headache • fever • cough due to minor throat and bronchial irritation.

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: • sore throat • minor aches and pains • runny nose and sneezing • headache • fever • cough due to minor throat and bronchial irritation.

Dosage & Administration

Directions • take only as directed (see overdose warning) • measure only with dosing cup provided and keep dosage cup with product • mL=mililiter • do not exceed 4 doses per 24 hours Age Dose adults and children 12 years and over 30 mL every 6 hours children under 12 years do not use

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: • adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product • taken with other drugs containing acetaminophen • adult has 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, lasts for mroe than 2 days, is accompanied or followed by fever, heacache, rash, nausea, or vomiting, consult a doctor promptly.
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. • if you have ever had an allergic reaction to this product or anay of its ingredients

When Using

When using this product • do not use more than directed (see overdose warning) • avoid alcoholic drinks • excitability may occur, especially in children • marked drowsiness may occur • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and 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 the reach of children.

Questions

Questions or comments? 1-844-912-4012


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