Children's TYLENOL® Plus FLU

CHILDRENS TYLENOL PLUS FLU - acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride suspension 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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.

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Drug Facts

Active ingredients
(in each 5 mL = 1 teaspoon)
Purpose
Acetaminophen 160 mgPain reliever/fever reducer
Chlorpheniramine maleate 1 mgAntihistamine
Dextromethorphan HBr 5 mgCough suppressant
Phenylephrine HCl 2.5 mgNasal decongestant

Uses

Warnings

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

  • with any other product containing acetaminophen
  • to make a child sleepy
  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dose (see overdose warning)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • 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 5 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.

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

Weight (lb)Age (yr)Dose (tsp or mL)
under 36under 4 yearsdo not use
36-474 to 5 yearsdo not use unless directed by a doctor
48-956 to 11 years2 tsp or 10 mL

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

Inactive ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

See New Warnings & Directions

NDC 50580-386-04

Children's
TYLENOL
®

Fever Reducer, Pain Reliever,
Cough Suppressant,
Nasal Decongestant,
Antihistamine

Plus

FLU

CONTAINS 4 INGREDIENTS:

BUBBLE
GUM

FLAVOR

4 FL OZ (120mL)

ORAL SUSPENSION

PRINCIPAL DISPLAY PANEL

CHILDRENS TYLENOL PLUS FLU 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-386
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (acetaminophen) Acetaminophen160 mg  in 5 mL
Chlorpheniramine Maleate (chlorpheniramine) Chlorpheniramine Maleate1 mg  in 5 mL
Dextromethorphan Hydrobromide (dextromethorphan) Dextromethorphan Hydrobromide5 mg  in 5 mL
Phenylephrine Hydrochloride (phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C Red NO. 33 
FD&C Red NO. 40 
glycerin 
cellulose, microcrystalline 
carboxymethylcellulose sodium 
water 
sodium benzoate 
sorbitol 
sucrose 
xanthan gum 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:50580-386-041 BOTTLE in 1 CARTONcontains a BOTTLE
1120 mL in 1 BOTTLEThis package is contained within the CARTON (50580-386-04)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/200612/31/2011

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 01/2013 McNeil Consumer Healthcare Div McNeil-PPC, Inc