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Acetaminophen by Rebel Distributors Corp

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-007

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 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

Principal Display Panel

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-007(NDC:51645-703)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint CodeGPI;A325
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-007-3030 TABLET (TABLET) in 1 BOTTLE
2NDC:21695-007-6060 TABLET (TABLET) in 1 BOTTLE
3NDC:21695-007-00100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/2007
ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-008(NDC:51645-706)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize14mm
FlavorImprint CodeGPI;A5
Contains    
Packaging
#Item CodePackage Description
1NDC:21695-008-1414 TABLET (TABLET) in 1 BOTTLE
2NDC:21695-008-1515 TABLET (TABLET) in 1 BOTTLE
3NDC:21695-008-2020 TABLET (TABLET) in 1 BOTTLE
4NDC:21695-008-3030 TABLET (TABLET) in 1 BOTTLE
5NDC:21695-008-5050 TABLET (TABLET) in 1 BOTTLE
6NDC:21695-008-6060 TABLET (TABLET) in 1 BOTTLE
7NDC:21695-008-00100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/2007
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 02/2011
 
Rebel Distributors Corp

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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