OTC Medication Information: Sunmark Junior Rapid Melts

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.

Active ingredient (in each tablet)

Acetaminophen 160 mg

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 the child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen.

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 20-25o C(68-77o F)
  • 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 Tablets

Box
(click image for full-size original)

SUNMARK JUNIOR RAPID MELTS
acetaminophen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-063
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
D&C RED NO. 27
DEXTROSE
FD&C BLUE NO. 1
MAGNESIUM STEARATE
MALTODEXTRIN
MANNITOL
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
SORBITOL
SUCRALOSE
SILICON DIOXIDE
SODIUM POLYMETAPHOSPHATE
Product Characteristics
Color pink Score no score
Shape ROUND Size 16mm
Flavor BUBBLE GUM Imprint Code G220
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49348-063-04 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 6 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (49348-063-04)
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 Operations
Guardian Drug Company 119210276 manufacture (49348-063)

Revised: 04/2014 Mckesson

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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