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Flu Relief Therapy Night Time by P & L Development, LLC

Medically reviewed on February 1, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: P & L Development, LLC
NDC Code: 49580-2004

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.

Drug Facts

Active ingredients (in each 15 mL, 1 tablespoon)

Acetaminophen  325 mg
Diphenhydramine HCl  12.5 mg
Phenylephrine HCI  5 mg

Purpose

Pain reliever/fever reducer
Antihistamine/Cough suppressant
Nasal decongestant

Uses

temporarily relieves

  • minor aches and pains
  • sneezing
  • headache
  • minor sore throat pain
  • itchy, watery eyes
  • nasal and sinus congestion
  • runny nose
  • cough due to minor throat and bronchial irritation
  • itchy nose or throat
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, rash, nausea, or vomiting, consult a doctor promptly.

Do not use
  • to make a child sleepy
  • 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 two 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 product containing diphenhydramine, even one used on skin
  • with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive in this product

Ask a doctor before use if you have
  • liver disease
  • glaucoma
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabtetes
  • cough accompanied by excessive phlegm (mucus)
  • 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 or emphysema

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)
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase dorwsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if
  • redness or swelling is present
  • nervousness, dizziness, or sleeplessness occurs
  • pain, cough or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with a fever, 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) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not use in infants
  • do not exceed recommended dose (see overdose warning)
  • use dosage cup provided
  • tbsp=tablespoon, mL= milliliter
age dose
adults and children 12 years and over 2 tablespoons (30 mL) every 4 hours
children 4 to 11 years do not use unless directed by a doctor
children under 4 years do not use

Other Information
  • each 15 mL contains: potassium 5 mg, sodium 7 mg
  • store at room temperature

Inactive Ingredients

acesulfame potassium, alcohol,FD&C blue 1, FD&C red 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to active ingredients in Theraflu® Nighttime*

Flu Relief Therapy

Nighttime cold and cough

Acetaminophen

Diphenhydramine HCl

Phenylephrine HCl

Cherry flavor

relieves:

  • aches, fever & sore throat
  • cough & runny nose
  • stuffy nose

for ages 12 & over

alcohol 10%

FL OZ (mL)

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE CAP IS BROKEN IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owber of the registered trademark Theraflu® Nighttime.

Fzailure to follow the drug facts warnings could result in serious consequences

Package Label

ReadyInCase Flu Relief Therapy Liquid

 

FLU RELIEF THERAPY NIGHT TIME 
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-2004
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) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ALCOHOL 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Theraflu Type Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49580-2004-8245 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/2009
Labeler - P & L Development, LLC (101896231)

 
P & L Development, LLC

← See all Flu Relief Therapy Night Time brands

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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