ACETAMINOPHEN- acetaminophen tablet, chewable 
Rebel Distributors Corp

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.

----------

Acetaminophen Drug Facts

Active ingredient

Acetaminophen

Purpose

Pain Reliever / Fever Reducer

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Uses

temporarily reduces fever and relieves minor aches and pains caused by

headache
common cold
flu
toothache
sore throat

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the 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, lasts for more than 2 days or is accompanied or fillowed 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.

Ask a doctor before use if the child has liver disease

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.

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

redness or swelling is present

any new symptoms appear

Directions

this product does not contain directions or complete warnings for adult use

find correct does on chart below

if possible, use weight to dose, otherwise use age

chew tablets before swallowing

give dose every 4 hours while symptoms last

do not give more than 5 doses in 24 hours

Weight
(pounds)
Age
(years)
Dose
(tablets)
72 - 9511 - 124 - 6
60 - 719 - 104 - 5
48 - 596 - 84
36 - 474 - 53
24 - 352 - 32
under 24under 2ask a doctor

Inactive ingredients

Package/Label Principal Display Panel

Acetaminophen 80mg

ACETAMINOPHEN 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42254-155(NDC:0536-3233)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
SUCROSE 
D&C RED NO. 27 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
Product Characteristics
ColorPINK (Light) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code Logo;051
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42254-155-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/16/2012
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
NameAddressID/FEIBusiness Operations
PSS World Medical, Inc.791528623REPACK(42254-155)
Establishment
NameAddressID/FEIBusiness Operations
STAT RX USA LLC786036330REPACK(42254-155)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785RELABEL(42254-155), REPACK(42254-155)
Establishment
NameAddressID/FEIBusiness Operations
SCRIPT PAK964420108RELABEL(42254-155), REPACK(42254-155)
Establishment
NameAddressID/FEIBusiness Operations
Keltman Pharmaceuticals, Inc.362861077REPACK(42254-155)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distirbutors Corp.118802834RELABEL(42254-155), REPACK(42254-155)

Revised: 2/2012
Document Id: 5c0dbae2-328b-42b6-a8b6-55009f3c78e5
Set id: 5c0dbae2-328b-42b6-a8b6-55009f3c78e5
Version: 1
Effective Time: 20120216
 
Rebel Distributors Corp