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

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