PAIN AND FEVER RELIEF CHILDRENS- acetaminophen suspension
Cardinal Health (Leader) 70000
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.
Acetaminophen 160 mg
Pain reliever/fever reducer
- temporarily reduces fever
- temporarily relieves minor aches and pains due to:
- the common cold
- sore throat
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
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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
taking the blood thinning drug warfarin.
do not exceed recommended dose (see Overdose warning)
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
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 (1-800-222-1222) right away. 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 take more than directed (see Overdose warning)
- shake well before using
- mL = milliliter
- use only the enclosed dosing cup designed for use with this product. do not use any other dosing device
- if needed, repeat dose every 4 hours while symptoms last
- do not gve more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age
|Weight (lb)||Age (year)||Dose (mL)|
|under 24||under 2||ask a doctor|
- each 5 mL contains: sodium 2 mg
- store between 20-25ºC (68-77ºF)
- do not refrigerate
- see bottom panel for lot number and expiration date
butylparaben, carboxymethylcellulose sodium, citric acid, D&C red #33, FD&C blue #1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Pain & Fever
160 mg per 5 mL
Fever Reducer, Pain Reliever
Ages 2-11 Years
FL OZ (mL)
COMPARE TO CHILDREN’s TYLENOL® ORAL SUSPENSION active ingredient**
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children’s Tylenol® Oral Suspension.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
LEADER Children’s Pain & Fever
| PAIN AND FEVER RELIEF
|Labeler — Cardinal Health (Leader) 70000 (063997360)|
Revised: 09/2021 Cardinal Health (Leader) 70000
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.