FDA Label for Meijer Childrens Pain And Fever Reducer
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)
- PURPOSE
- USES
- WARNINGS
- SORE THROAT WARNING:
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS ?
- PRINCIPAL DISPLAY PANEL
Meijer Childrens Pain And Fever Reducer Product Label
The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Chewable Tablet)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
▪ temporarily relieves minor aches and pains due to:▪ the common cold▪ flu▪ headache▪ sore throat▪ toothache
▪ 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.▪ skin reddening▪ blister▪ rash▪ If a skin reaction occurs, stop use and seek medical help right away.
Allergy Alert:
acetaminophen may cause severe skin reaction. Symptom may include:
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.▪ if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask A Doctor Before Use If Your Child Has
liver disease.
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 dose (see overdose warning)
Stop Use And Ask A Doctor If
▪ pain gets worse or lasts more than 5 days▪ fever gets worse or lasts more than 3 days▪ new symptoms occur▪ redness or swelling is present
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 at 1-800-222-1222. Quick medical attention is critical 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)• find the right dose on chart below. If possible, use weight to dose; otherwise use age.• chew completely do not swallow whole• repeat dose every 4 hours while symptoms last• do not give more than 5 times in 24 hours
Weight (lbs) | under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 |
Age (yr) | under 2 years | 2-3 years | 4-5 years | 6-8 years | 9-10 years | 11 years |
Dose (tablets)* | ask a doctor | 1 tablet | 1 ½ tablets | 2 tablets | 2 ½ tablets | 3 tablets |
Other Information
• store at room temperature. Avoid high humidity. Protect from light.• see end flap for expiration date and lot number
Inactive Ingredients
citric acid, crospovidone, D&C Red No. 30, dextrose, flavor, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethylcellulose, starch, sucralose.
Questions Or Comments ?
1-866-467-2748
Principal Display Panel
NDC 41250-246-24
Compare to active ingredient in Children’s Tylenol® Chewables*
Children’s
Pain + Fever Chewables
ACETAMINOPHEN
Pain reliever/Fever reducer
Aspirin free
Ibuprofen free
AGES 2-11
Bubblegum Flavor
Naturally and Artificially Flavored
24 Chewable Tablets – 160 mg each
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol® Chewables.
IMPORTANT: Keep this carton for future reference on full labeling. |
Distributed by:
MEIJER DISTRIBUTION INC
GRAND RAPIDS, MI, 49544
www.meijer.com
* Please review the disclaimer below.