PAIN RELIEVER CHILDREN- 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 44-185

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

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

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

 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

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?

1-800-426-9391

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NDC 15127-185-01

Ibuprofen Free
Aspirin Free

Ages 2-6
Children's
Pain Reliever
Acetaminophen 80 mg

PAIN RELIEVER / FEVER REDUCER

Compare to the Active Ingredient of Children’s Tylenol® Meltaways®

30 Chewable Tablets

Fruit Flavored

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      REV0416A18501

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

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brand®
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Select Brand 44-185

Select Brand 44-185

PAIN RELIEVER  CHILDREN
acetaminophen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-185
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
ASPARTAME (UNII: Z0H242BBR1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10mm
Flavor FRUIT Imprint Code 44;185
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:15127-185-01 1 in 1 CARTON 09/06/2001 08/29/2020
1 30 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 09/06/2001 08/29/2020
Labeler - L&R Distributors, Inc. (012578514)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(15127-185)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(15127-185)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 PACK(15127-185)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 PACK(15127-185)

Revised: 8/2017
Document Id: d5723743-b65a-4142-9391-f396c15333d1
Set id: a05ce81c-9fb8-45e9-abf1-003420cdf729
Version: 4
Effective Time: 20170830
 
L&R Distributors, Inc.