SUNMARK JUNIOR RAPID MELTS- acetaminophen tablet, chewable 
Mckesson

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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junior rapid melts

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/ fever reducer

Uses

temporarily relieves minor aches and pains due to:

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

Do not use

  • with any other product containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

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

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition

Keep out of reach of children.

Overdose warning: Thaking 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 dose
  • do not give more than directed (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 while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor.
 Weight (lb)  Age (yr)  Tablets
 under 48 lbs  under 6 years  ask a doctor
 48-59 lbs  6-8 years  2
 60-71 lbs  9-10 years  2 1/2
 72-95 lbs  11 years  3

Other information
  • store at controlled room temperature betweeen 20-25oC(68-77oF)
  • see end flap for expiration date and lot number

Inactive ingredients

acesulfame pottasium, citric acid, D&C red 27 aluminum lake, dextrose, FD&C blue 1 aluminum lake, flavors, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose powder, polyplasdone, sorbitol, sucralose.

May contain ethylcellulose, gelatin, sodium polyphosphate, silicon dioxide.

PDP

Sunmark

Junior Rapid Melts

Compare to JR. Tylenol Meltaways active ingredient

Pain reliever

Fever reducer

Acetaminophen

Pain reliever/Fever Reducer

For ages 6-11 years

Bubblegum Flavor

24 TabletsBox

SUNMARK JUNIOR RAPID MELTS 
acetaminophen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-063
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 68401960MK)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
Product Characteristics
Color pink Score no score
Shape ROUND Size 16mm
Flavor BUBBLE GUM Imprint Code G220
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-063-04 4 in 1 CARTON
1 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 08/01/2013
Labeler - Mckesson (177667227)
Registrant - Guardian Drug Company (119210276)
Establishment
Name Address ID/FEI Business Operations
Guardian Drug Company 119210276 manufacture(49348-063)

Revised: 4/2014
Document Id: ff130d3b-4acc-4a1b-80b9-4077f6e672b3
Set id: b1df684d-8ee6-41c6-ba19-78a2d8d20d81
Version: 1
Effective Time: 20140407
 
Mckesson