CHILDRENS CHEWABLE PAIN RELIEVER- acetaminophen tablet, chewable 
L.N.K. International, 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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Quality Plus 44-185-Delisted

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer 

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • flu
    • toothache
    • sore throat
  • 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 dose. 

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children 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 give more than directed
  • 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

  • Phenylketonurics: Contains Phenylalanine 6 mg per tablet
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, ethylcellulose, flavor, magnesium stearate, mannitol, NutraSweet (aspartame), polyethylene, stearic acid

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

QUALITY
+ PLUS

NDC 50844-185-08

Compare to the active ingredient in Children's Tylenol® Meltaways®

Children's Chewable
PAIN RELIEVER
Acetaminophen
80 mg
PAIN RELIEVER /
FEVER REDUCER

• Ibuprofen Free    • Aspirin Free     • Fruit Flavored

24
Tablets            
AGES 2-6

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    REV0416B18508

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA
Quality Plus 44-185

Quality Plus 44-185

CHILDRENS CHEWABLE PAIN RELIEVER 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-185
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ASPARTAME (UNII: Z0H242BBR1)  
MANNITOL (UNII: 3OWL53L36A)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize10mm
FlavorFRUITImprint Code 44;185
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-185-081 in 1 CARTON04/10/199008/29/2020
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/10/199008/29/2020
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(50844-185)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(50844-185)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(50844-185)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(50844-185)

Revised: 1/2018
 
L.N.K. International, Inc.