CHILDRENS TYLENOL COLD PLUS FLU- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride suspension

Childrens TYLENOL by

Drug Labeling and Warnings

Childrens TYLENOL by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL)	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

• temporarily relieves the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • cough
  • stuffy nose
  • sneezing and runny nose
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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 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.
• 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.
• if your child is allergic to any of the ingredients in this product

Ask a doctor before use if your child has

• liver disease
• 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 your child is

• taking the blood thinning drug warfarin
• 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

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

• this product does not contain directions or complete warnings for adult use.
• do not give more than directed (see overdose warning)
• shake well before using
• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• remove the child protective cap and squeeze your child's dose into the dosing cup
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL)*
* or as directed by a doctor
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	10 mL

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

Other information

• store between 20-25°C (68-77°F)
• do not use if carton is opened or if carton tape or bottle wrap imprinted "TYLENOL" is broken or missing

Inactive ingredients

anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions or comments?

call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC: 50580-299-01

Children's
TYLENOL®

COLD +
FLU

Acetaminophen, Pain Reliever-Fever Reducer
Chlorpheniramine Maleate, Antihistamine
Dextromethorphan HBr, Cough Suppressant
Phenylephrine HCl, Nasal Decongestant

Oral Suspension

Ages 6-11 Years

☑ FEVER
☑ SORE THROAT
☑ SNEEZING
☑ RUNNY NOSE
☑ COUGH
☑ STUFFY NOSE

Grape
Flavor

4 fl oz (120 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS TYLENOL   COLD PLUS FLU
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-299
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	160 mg  in 5 mL
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)	Chlorpheniramine Maleate	1 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	5 mg  in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C red no. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
microcrystalline cellulose (UNII: OP1R32D61U)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucrose (UNII: C151H8M554)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-299-01	1 in 1 CARTON	06/26/2017
1		120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/26/2017

Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)