Tylenol Allergy Multi-Symptom Nighttime

Dosage form: tablet, film coated
Ingredients: acetaminophen 325mg, diphenhydramine Hydrochloride 25mg, phenylephrine Hydrochloride 5mg
Labeler: McNeil Consumer Healthcare Div McNeil-PPC, Inc
NDC Code: 50580-283

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.

TYLENOL®
ALLERGY
MULTI-SYMPTOM
NIGHTTIME

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • temporarily relieves these symptoms of hay fever or other respiratory allergies:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • runny nose and sneezing
    • minor aches and pains
  • temporarily relieves these additional symptoms of hay fever:
    • itching of the nose or throat
    • itchy, watery eyes
  • helps clear nasal passages

Warnings

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use

  • with any other product containing acetaminophen
  • with any other product containing diphenhydramine, even one used on skin
  • 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.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion 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

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 right away. (1-800-222-1222) 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 take more than directed (see overdose warning)
adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole - do not crush, chew or dissolve
  • do not take more than 12 caplets in 24 hours
children under 12 yearsdo not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if blister unit is broken
  • see side panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, flavors, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, propylene glycol, potassium sorbate, shellac, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide, triacetin

Questions or comments?

call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)

PRINCIPAL DISPLAY PANEL

NDC 50580-283-24

TYLENOL®

ALLERGY
MULTI-SYMPTOM

Pain Reliever, Nasal Decongestant, Antihistamine

CONTAINS 3 MEDICINES:

Headache
Acetaminophen

Sinus Pressure
Nasal Congestion
Phenylephrine HCl

Runny Nose/Sneezing
Itchy, Watery Eyes
Diphenhydramine HCl

NIGHTTIME

24
Cool Burst™
CAPLETS

TYLENOL ALLERGY MULTI-SYMPTOM NIGHTTIME 
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-283
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen325 mg
diphenhydramine Hydrochloride (diphenhydramine) diphenhydramine Hydrochloride25 mg
phenylephrine Hydrochloride (phenylephrine) phenylephrine Hydrochloride5 mg
Product Characteristics
ColorYELLOW (Light yellow) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code TY;Allergy;NT
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-283-121 BLISTER PACK (BLISTER PACK) in 1 CARTON
112 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
2NDC:50580-283-242 BLISTER PACK (BLISTER PACK) in 1 CARTON
212 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2006
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 04/2010
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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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