Skip to Content

← See all Childrens Acetaminophen brands

Childrens Acetaminophen by GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Medically reviewed on January 25, 2018

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg
Labeler: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
NDC Code: 64092-031

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.

Healthcare 44-447-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 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.

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 24Under 2Ask a doctor
24-352-32
36-474-53
48-596-84
60-719-105
72-95116

*or as directed by a doctor

Other information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
  • avoid high humidity

Inactive ingredients

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

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

HEALTHCARE

NDC 64092-031-20

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

Children's
ACETAMINOPHEN

Pain Reliever • Fever Reducer
Aspirin Free • Ibuprofen Free

Rapid Tabs

Bubble Gum
Flavor

AGES 2-6

20 Chewable Tablets 80 mg EACH

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      REV0416E44709

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
www.glwholesale.com

HEALTHCARE GUARANTEE
If you are not completely satisfied with this
product, regardless of reason, return your unused
portion to Great Lakes Wholesale for a full refund

Healthcare 44-447

CHILDRENS ACETAMINOPHEN 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-031
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 27 
D&C RED NO. 30 
ETHYLCELLULOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MANNITOL 
STEARIC ACID 
SUCRALOSE 
CROSPOVIDONE, UNSPECIFIED 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize13mm
FlavorBUBBLE GUMImprint Code44;447
Contains    
Packaging
#Item CodePackage Description
1NDC:64092-031-201 BOTTLE, PLASTIC in 1 CARTON
120 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/03/200511/28/2020
Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(64092-031)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(64092-031)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(64092-031)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(64092-031)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(64092-031)

 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

← See all Childrens Acetaminophen brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide