CHILDRENS TYLENOL PLUS COLD AND ALLERGY
-
acetaminophen,
diphenhydramine hydrochloride 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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Active ingredients (in each 5 mL = 1 teaspoon) | Purpose |
Acetaminophen 160 mg | Pain reliever/fever reducer |
Diphenhydramine HCl 12.5 mg | Antihistamine |
Phenylephrine HCl 2.5 mg | Nasal decongestant |
Uses
- for the temporary relief of the following cold and hay fever or other upper respiratory allergy symptoms:
- minor aches and pains
- headache
- sore throat
- itchy, watery eyes
- itching of the nose or throat
- sneezing
- runny nose
- nasal congestion
- stuffy 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
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
- with any other product containing diphenhydramine, even one used on the skin
- 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 has ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if your child has
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- 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 or nasal congestion 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
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
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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
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- if needed, repeat dose every 4 hours
- do not give more than 5 times in 24 hours
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
- store between 20-25°C (68-77°F)
-
do not use if bottle wrap, or foil inner seal imprinted
"Safety Seal®" is broken or missing
- see bottom panel for lot number and expiration date
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, sucralose, sucrose, xanthan gum
Questions or comments?
call 1-877-895-3665
PRINCIPAL DISPLAY PANEL
See New Warnings Information
NDC 50580-390-04
Children's
TYLENOL®
Plus
COLD &
ALLERGY
-
Fever & Sore Throat
Acetaminophen
-
Itchy, Watery
Eyes, Sneezing
& Runny Nose
Diphenhydramine HCl
-
Stuffy Nose
Phenylephrine HCl
BUBBLE GUM
FLAVOR
4 FL OZ (120mL)
ORAL SUSPENSION
CHILDRENS TYLENOL PLUS COLD AND ALLERGY
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride suspension |
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Revised: 12/2012 McNeil Consumer Healthcare Div McNeil-PPC, Inc