Acetaminophen by Rebel Distributors Corp ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Acetaminophen 325mg

Acetaminophen 500mg

PURPOSE

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-007(NDC:51645-703)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 68401960MK)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	GPI;A325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-007-30	30 in 1 BOTTLE
2	NDC: 21695-007-60	60 in 1 BOTTLE
3	NDC: 21695-007-00	100 in 1 BOTTLE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 68401960MK)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-008-14	14 in 1 BOTTLE
2	NDC: 21695-008-15	15 in 1 BOTTLE
3	NDC: 21695-008-20	20 in 1 BOTTLE
4	NDC: 21695-008-30	30 in 1 BOTTLE
5	NDC: 21695-008-50	50 in 1 BOTTLE
6	NDC: 21695-008-60	60 in 1 BOTTLE
7	NDC: 21695-008-00	100 in 1 BOTTLE

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	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK