childrens pain relief plus
- Clinical Pharmacology
- Indications & Usage
- Side Effects
- Dosage & Administration
- How Supplied
- Patient Counseling Information
- Supplemental Patient Material
- Boxed Warning
- Patient Package Insert
FULL PRESCRIBING INFORMATION: CONTENTS*
- Active ingredient (in each 5 mL = 1 teaspoon)
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
FULL PRESCRIBING INFORMATION
Active ingredient (in each 5 mL = 1 teaspoon)
Acetaminophen 160 mg
Dextromethorphan HBr 5 mg
Pain reliever/fever reducer
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- temporarily reduces fever
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
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if your child has
- liver disease
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if your child is
taking the blood thinning drug warfarin
When using this product
do not exceed recommended dosage
Stop use and ask a doctor if
- pain 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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.
- this product does not contain directions or complete warnings for adult use
- do not use more than directed (see Liver 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||1 tsp or 5 mL|
|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.
- each teaspoon contains: sodium 3 mg
- store at 20°-25°C (68°-77°F)
- do not use if printed neckband is broken or missing
carrageenan, citric acid, D&C red no. 33, edetate disodium, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, polysorbate 80, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions or comments?
Principal Display Panel
Compare to active ingredients of Children’s Tylenol® Plus Cough & Sore Throat - see back panel
For Ages 4 to 11
See New Warnings Information
Pain Relief Plus
Cough & Sore Throat
Fever Reducer/Pain Reliever/Acetaminophen
Cough Suppressant/Dextromethorphan HBr
Dosage Cup Included
childrens pain relief plus
Acetaminophen, Dextromethorphan HBr SUSPENSION