PAIN RELIEVER JUNIOR STRENGTH- acetaminophen tablet, chewable 
L&R Distributors, 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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Select Brand 44-449-delisted

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

  • this product does not contain directions or complete warnings for adult use
  • dissolve in mouth or chew before swallowing
  • if needed, repeat dose every 4 hours while symptoms last
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • 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) Tablets
 Under 48 Under 6 Ask a doctor
 48-59 6-8 2
 60-71 9-10 2 1/2
 72-95 11 3

Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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 hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 15127-877-24

select brand®
the lower price name brand

JUNIOR STRENGTH
PAIN RELIEVER
ACETAMINOPHEN

• PAIN RELIEVER / FEVER REDUCER
• NON-ASPIRIN
• MELTS IN YOUR MOUTH
For Children Ages 6 to 11

*Compare to the Active Ingredient of Junior Strength Tylenol® Meltaways®

24 Fast Melting Tablets - 160 mg each

GRAPE FLAVOR

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS
TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
 

*This product is not manufactured or distributed by McNeil Consumer Healthcare,
owner of the registered trademark Junior Strength Tylenol® Meltaways®.
50844         ORG021344908

Distributed by:
SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603  USA
AC (870) 535-3635

Select Brand 44-449

Select Brand 44-449

PAIN RELIEVER  JUNIOR STRENGTH
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-877
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSPOVIDONE (UNII: 2S7830E561)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Product Characteristics
ColorPURPLEScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code 44;449
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-877-244 in 1 CARTON01/28/200509/10/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/28/200509/10/2021
Labeler - L&R Distributors, Inc. (012578514)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(15127-877)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(15127-877)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(15127-877)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(15127-877)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(15127-877)

Revised: 6/2019
 
L&R Distributors, Inc.