RAPID MELTS CHILDRENS- acetaminophen tablet, chewable 
CHAIN DRUG MARKETING ASSOCIATION 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.

----------

Quality Choice 44-452

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • flu
    • sore throat
    • toothache
  • 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 the maximum daily amount
  • with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 dosage.

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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • do not give more than directed (see overdose warning)
  • this product does not contain directions or complete warnings for adult use
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor

Weight (lb)

Age (yr)

Dose (tablets)*

Under 24

Under 2

Ask a doctor

24-35

2-3

2

36-47

4-5

3

48-59

6-8

4

60-71

9-10

5

72-95

11

6

*or as directed by a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • protect from light
  • see end flap for expiration date and lot number

Inactive ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions?

Call 1-800-426-9391

Principal Display Panel

QC®
QUALITY
CHOICE

NDC 63868-033-30

Compare to the
active ingredient in
CHILDREN’S TYLENOL®
MELTAWAYS®†

Ages 2-6
Children’s Rapid Melts

Acetaminophen, 80 mg

Pain Reliever/
Fever Reducer
Aspirin Free | Ibuprofen Free

Grape
Flavor

30 Tablets

Actual Size

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

†This product is not manufactured or
distributed by McNeil Consumer
Healthcare, owner of the registered
trademark Children’s Tylenol®
Meltaways®.

50844       ORG101345201

SATISFACTION
GUARANTEED
100%
QC

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Quality Choice 44-452

Quality Choice 44-452

RAPID MELTS  CHILDRENS
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-033
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTRATES (UNII: G263MI44RU)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint Code 44;452
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-033-301 in 1 CARTON12/06/200409/21/2020
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/06/200409/21/2020
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63868-033)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63868-033)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(63868-033)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(63868-033)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(63868-033)

Revised: 10/2017
Document Id: feed1f88-cb4b-42bf-8c1e-5872983204ff
Set id: 998e2cdc-4115-45f2-944c-bf97b8c407b3
Version: 4
Effective Time: 20171025
 
CHAIN DRUG MARKETING ASSOCIATION INC