ACETAMINOPHEN tablet, chewable

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp, PSS World Medical, Inc., STAT RX USA LLC, Dispensing Solutions, Inc., SCRIPT PAK, Keltman Pharmaceuticals, Inc., Rebel Distirbutors Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42254-155(NDC: 0536-3233)
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
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)