JUNIOR STRENGTH PAIN RELIEF - acetaminophen tablet 
Capricorn Pharma Inc.

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.

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Drug Facts

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.

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.

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

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 20-25ºC (68-77ºF). 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 Pharma
ORIGINAL DEVELOPERS AND MANUFACTURERS
Compare to the active ingredient of Junior Tylenol Meltaways
JUNIOR STRENGTH
Pain Relief
ACETAMINOPHEN - 160mg each
For Children Ages 6-11

See new warnings information

    * Fever Reducer
    * Pain Reliever
    * Contains no Aspirin
    * Melts in your mouth

RAPIDMELT

24 Fast Dissolving Tablets

Grape Flavor
Junior strength Pain Relief Acetaminophen 160mg

JUNIOR STRENGTH PAIN RELIEF 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66007-145
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Product Characteristics
Colorpurple (light purple/violet) Score2 pieces
ShapeROUND (Round Lozenge) Size14mm
FlavorGRAPEImprint Code CP
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66007-145-024 in 1 CARTON
1NDC:66007-145-016 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/26/2010
Labeler - Capricorn Pharma Inc. (041704524)
Registrant - Capricorn Pharma Inc. (041704524)
Establishment
NameAddressID/FEIBusiness Operations
Capricorn Pharma Inc.041704524manufacture

Revised: 7/2010
Document Id: a7e74856-eb57-4153-bae9-008f0cfdbbf9
Set id: 9fa0eaa3-d9c6-45c8-9613-edf9e50021e9
Version: 1
Effective Time: 20100726
 
Capricorn Pharma Inc.