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 mg Pain reliever/fever reducer
Chlorpheniramine maleate 1 mg Antihistamine
Dextromethorphan HBr 5 mg Cough suppressant
Phenylephrine HCl 2.5 mg Nasal 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 36 under 4 years do not use
36-47 4 to 5 years do not use unless directed by a doctor
48-95 6 to 11 years 2 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 Type HUMAN OTC DRUG Item Code (Source) NDC:50580-386
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (acetaminophen) Acetaminophen 160 mg  in 5 mL
Chlorpheniramine Maleate (chlorpheniramine) Chlorpheniramine Maleate 1 mg  in 5 mL
Dextromethorphan Hydrobromide (dextromethorphan) Dextromethorphan Hydrobromide 5 mg  in 5 mL
Phenylephrine Hydrochloride (phenylephrine) Phenylephrine Hydrochloride 2.5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Color PINK Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50580-386-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 120 mL in 1 BOTTLE This package is contained within the CARTON (50580-386-04)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/01/2006 12/31/2011

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

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