FDA Label for Junior Strength Pain Relief
View Indications, Usage & Precautions
Junior Strength Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Capricorn Pharma 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 Tablet)
Acetaminophen 160mg
Purpose
Pain Reliever/Fever Reducer
Uses
temporarily relieves minor aches and pains due to:
■ the common cold
■ flu
■ headache
■ 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 maximum daily amount
■ with other drugs containing acetaminophen
Do Not Use
■ with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Stop Use And Ask Doctor If
■ new symptoms occur
■ redness or swelling is present
■ pain gets worse or lasts for more than 5 days
■ fever gets worse or lasts for more than 3 days
Otc - Keep Out Of Reach Of Children
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. 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 exceed recommended dose (see overdose warning)
■ find right dose on chart below. If possible, use weight to dose; otherwise, use age
■ dissolve in mouth or chew before swallowing
■ if needed, repeat dose every 4 hours
■ do not use more than 5 times in 24 hours
Weight (lb) | Under 48 | 48-59 | 60-71 | 72-95 | 96 and over |
Age (yr) | Under 6 | 6-8 | 9-10 | 11 | 12 |
Tablets | Ask a doctor | 2 | 2-1/2 | 3 | 4 |
Other Information
■ Do not use if blister unit is broken or shows signs of tampering.
■ Store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
■ See end panel for lot number and expiration date.
Inactive Ingredient
Crospovidone, D & C red # 7, D & C red # 30, ethylcellulose, FD & C blue # 1, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, sucralose, talc, triethyl citrate
Principal Display Panel
Capricorn PharmaORIGINAL DEVELOPERS AND MANUFACTURERSCompare to the active ingredient of Junior Tylenol MeltawaysJUNIOR STRENGTHPain Relief ACETAMINOPHEN - 160mg eachFor Children Ages 6-11See new warnings information * Fever Reducer * Pain Reliever * Contains no Aspirin * Melts in your mouthRAPIDMELT24 Fast Dissolving TabletsGrape Flavor
* Please review the disclaimer below.