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Name:Acetaminophen
Manufacturer:Rebel Distributors Corp
Category:Over-the-counter (OTC) Marketed Drugs


Acetaminophen Drug Facts

ACETAMINOPHEN - acetaminophen tablet 
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 325mg

Acetaminophen 500mg

Keep Out of Reach of Children

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as children, even if you do not notice symptoms or signs.

Uses

Use for temporary relief of minor aches and pains due to:

° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever

Warnings

Alcohol Warning: If you consume 3 or more alcoholic beverages every day, ask your doctor whether you should take Acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use with any other product containing Acetaminophen or if you have ever had an allergic reaction to pain relievers/fever reducers.

Stop use and ask a doctor if

° new symptoms occur ° redness or swelling is present ° pain gets worse or lasts more than 10 days ° fever gets worse or lasts more than 3 days.

If pregnant or breast-feeding, ask a doctor before use.

Directions

Do not take more than directed

° adults and children 12 years and older, take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. ° children under 12, consult a doctor before use.

Other Information

For your protection, this bottle has an imprinted Safety Seal under cap. Do not use if Safety Seal is broken or missing.

Store at room temperature.

Questions? To report an adverse drug effect, contact 1-800-795-9775.

Inactive ingredients

Crospovidone, Povidone, Pregelatinized Starch, Stearic Acid.

Distributed by:

Plus PharmaCommack

New York 11725

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

Acetaminophen 325mg

Principal Display Panel

Acetaminophen 500mg


ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-007(NDC:51645-703)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE  
POVIDONE  
STARCH, CORN  
STEARIC ACID  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code GPI;A325
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-007-30 30 TABLET ( TABLET) in 1 BOTTLE None
2 NDC:21695-007-60 60 TABLET ( TABLET) in 1 BOTTLE None
3 NDC:21695-007-00 100 TABLET ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 01/01/2007

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-008(NDC:51645-706)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE  
POVIDONE  
STARCH, CORN  
STEARIC ACID  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 14mm
Flavor Imprint Code GPI;A5
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-008-14 14 TABLET ( TABLET) in 1 BOTTLE None
2 NDC:21695-008-15 15 TABLET ( TABLET) in 1 BOTTLE None
3 NDC:21695-008-20 20 TABLET ( TABLET) in 1 BOTTLE None
4 NDC:21695-008-30 30 TABLET ( TABLET) in 1 BOTTLE None
5 NDC:21695-008-50 50 TABLET ( TABLET) in 1 BOTTLE None
6 NDC:21695-008-60 60 TABLET ( TABLET) in 1 BOTTLE None
7 NDC:21695-008-00 100 TABLET ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 01/01/2007

Labeler - Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 02/2011 Rebel Distributors Corp



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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