Junior Strength Pain Relief
FDA Label NDC 66007-145

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Capricorn Pharma Inc. for the product Junior Strength Pain Relief (NDC 66007-145). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(in each tablet), purpose, uses, warnings, do not use, otc - ask doctor/pharmacist, stop use and ask doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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