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Night Time Severe Cold and Cough Relief

Medically reviewed on April 7, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Discount Drug Mart
NDC Code: 53943-534

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Night Time Severe Cold & Cough Relief  534

Drug Facts
Active ingredients
(in each tablespoonful, 15 mL)

Acetaminophen 325 mg

Diphenhydramine HCL 12.5 mg

Phenylephrine HCL 5 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant/Antihistamine
Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • nasal and sinus congestion
  • runny nose
  • sneezing
  • itchy watery eyes
  • itchy nose or throat
  • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever

Warnings

Liver warning This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maxium daily amount
  • 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 a 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.f 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 diphenhydramine, even one used on skin
  • for children under 12 years of age

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, 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
    (see overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, seadtives, tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be carefuk when driving a motor vehicle or operating machinery

Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistanr headache. 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.

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 noitce any signs or symptoms.

Directions
  • take only as recommended (see Overdose warnings)
  • Use dosage cup or tablespoon (TBSP)
  • Do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

Age Dose

Children under                               Do not use
12 years of age

Adults & children                            2 tablespoomsful
12 tears and over                        

Other information
  • each tablespoonful (15 mL contains potassium 9 mg. sodium 6 mg
  • dosage cup provided
  • store between 20-25°C (68-77° F)
  • do not refigerate

Inactive ingredients

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate

Questions ?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Night Time Severe Cold & Cough Relief product label

DISCOUNT
drug
mart
FOOD FAIR

*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFLU® WARMING RELIEF NIGHT TIME SEVERE COLD & COUGH

LF-017

Night Time Senere Cold & Cough Relief

Acetaminophen ....................Pain Reliever /Fever Reducer
Diphenhydramine .................Antihistamine/ cough Suppressant       

Phenylephrine HCL ................Nasal Decongestant

  • Fever & Body Aches
  • Sore Throat
  • Headache
  • Nassal Decongestant
  • Runny nose
  • Cough

CHERRY FLAVOR

8.3 FL O (245 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

* This product is not manufactured or distributed by Novartis Consumer health Inc.,owne of the registered trademark Theraflu® Night Time.

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINIA, OHIO 44256

LB-017

Lot:
Exp:

NIGHT TIME SEVERE COLD AND COUGH RELIEF 
acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-534
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53943-534-30245 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/04/2016
Labeler - Discount Drug Mart (047741335)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIOperations
AptaPharma Inc.790523323manufacture(53943-534)

 
Discount Drug Mart

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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