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.

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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 - 95 11 - 12 4 - 6
60 - 71 9 - 10 4 - 5
48 - 59 6 - 8 4
36 - 47 4 - 5 3
24 - 35 2 - 3 2
under 24 under 2 ask a doctor

Inactive ingredients

Package/Label Principal Display Panel

Acetaminophen 80mg

ACETAMINOPHEN 
acetaminophen tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42254-155(NDC:0536-3233)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME (UNII: Z0H242BBR1)  
SUCROSE (UNII: C151H8M554)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color PINK (Light) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code Logo;051
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42254-155-30 30 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 02/16/2012
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Business Operations
PSS World Medical, Inc. 791528623 REPACK(42254-155)
Establishment
Name Address ID/FEI Business Operations
STAT RX USA LLC 786036330 REPACK(42254-155)
Establishment
Name Address ID/FEI Business Operations
Dispensing Solutions, Inc. 066070785 RELABEL(42254-155) , REPACK(42254-155)
Establishment
Name Address ID/FEI Business Operations
SCRIPT PAK 964420108 RELABEL(42254-155) , REPACK(42254-155)
Establishment
Name Address ID/FEI Business Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-155)
Establishment
Name Address ID/FEI Business Operations
Rebel Distirbutors Corp. 118802834 RELABEL(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