JUNIOR STRENGTH PAIN RELIEF- acetaminophen tablet

Junior Strength Pain Relief by

Drug Labeling and Warnings

Junior Strength Pain Relief by is a Otc medication manufactured, distributed, or labeled by Capricorn Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

JUNIOR STRENGTH PAIN RELIEF 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66007-145
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg

Product Characteristics
Color	purple (light purple/violet)	Score	2 pieces
Shape	ROUND (Round Lozenge)	Size	14mm
Flavor	GRAPE	Imprint Code	CP
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66007-145-02	4 in 1 CARTON
1	NDC: 66007-145-01	6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/26/2010

Labeler - Capricorn Pharma Inc. (041704524)

Registrant - Capricorn Pharma Inc. (041704524)

Establishment
Name	Address	ID/FEI	Business Operations
Capricorn Pharma Inc.		041704524	manufacture