Nighttime Cold and Flu ACETAMINOPHEN DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL RITE AID CORPORATION FDA Approved Uses temporarily relieves these common cold/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 ingredients (in each 20 mL) Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg
Inactive Ingredients
Inactive ingredients citric acid disodium EDTA FD&C blue #1 FD&C red #40 flavor glycerin propyl gallate propylene glycol purified water sodium benzoate sodium citrate sorbitol sucralose xanthan gum
Strengths
20 ml 650 mg 25 mg 10 mg
Treats Conditions
Uses Temporarily Relieves These Common Cold 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

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0011822685979
UNII
362O9ITL9D TC2D6JAD40 04JA59TNSJ
Packaging

Principal Display Panel Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu* MAXIMUM STRENGTH NIGHT TIME COLD & FLU MULTI-SYMPTOM RELIEF PAIN RELIEVER / FEVER REDUCER ANTIHISTAMINE / COUGH SUPPRESSANT NASAL DECONGESTANT ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HCl 25 mg PHENYLEPHRINE HCl 10 MG Temporarily relieves aches,fever, sore throat, nasal congestion, runny nose & sneezing Controls cough For ages 12 & over FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, distributor or Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com; Product Label RITE AID Maximum Strength Night Time Cold & Flu Acetaminophen 650 mg Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg; Package label RITE AID Maximum Strength Mucus Relief Severe Cold Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg; Package label RITE AID Maximum Strength Night Time Cold & Flu, Maximum Strength Mucus Relief Severe Cold Acetaminophen 650 mg, Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg, Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg

Package Descriptions
  • Principal Display Panel Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu* MAXIMUM STRENGTH NIGHT TIME COLD & FLU MULTI-SYMPTOM RELIEF PAIN RELIEVER / FEVER REDUCER ANTIHISTAMINE / COUGH SUPPRESSANT NASAL DECONGESTANT ACETAMINOPHEN 650 mg DIPHENHYDRAMINE HCl 25 mg PHENYLEPHRINE HCl 10 MG Temporarily relieves aches,fever, sore throat, nasal congestion, runny nose & sneezing Controls cough For ages 12 & over FL OZ (mL) *This product is not manufactured or distributed by Reckitt Benckiser, distributor or Maximum Strength Mucinex® Fast-Max® Night Time Cold & Flu TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011 www.riteaid.com
  • Product Label RITE AID Maximum Strength Night Time Cold & Flu Acetaminophen 650 mg Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg
  • Package label RITE AID Maximum Strength Mucus Relief Severe Cold Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg
  • Package label RITE AID Maximum Strength Night Time Cold & Flu, Maximum Strength Mucus Relief Severe Cold Acetaminophen 650 mg, Diphenhydramine HCl 25 mg, Phenylephrine HCl 10 mg, Acetaminophen 650 mg, Dextromethorphan HBr 20 mg, Guaifenesin 400 mg, Phenylephrine HCl 10 mg

Overview

Uses temporarily relieves these common cold/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/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 6 doses in any 24-hours period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product dose as follows or as directed by a doctor adults and children 12 years and over: 20 mL every 4 hours while symptoms last 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 4,000 mg of acetaminophen in 24 hours 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 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist with any other drug containing diphenhydramine, even one used on the skin for children under 12 years of age Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin sedatives or tranquilizers 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 and tranquilizers may increase drowsiness 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 (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

Purposes Pain reliever/fever reducer Antihistamine/Cough suppressant Nasal decongestant

Do Not Use

Do not use 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist with any other drug containing diphenhydramine, even one used on the skin for children under 12 years of age

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 and tranquilizers may increase drowsiness

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. 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 (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.

Storage & Handling

Other information each 20 mL contains : Sodium 12 mg store between 20-25ºC (68-77ºF). Do not refrigerate.


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