ACETAMINOPHEN by Cispharma, Inc ACETAMINOPHEN tablet

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by Cispharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Acetaminophen .....................500 mg

PURPOSE

Pain Reliever/ Fever Reducer

Uses

Temporarily relieves minor aches and pains due to:

• headache
• the common cold
• backache
• muscular aches
• minor pain of arthritis
• toothache
• premenstrual and menstrual cramps

temporarily reduces fever

Warnings

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

Do not use with any other drug containing acetaminophen

Stop use and ask a doctor if

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

These could be signs of a serious condition.

Indicated for pain relief.

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

Keep out of reach of children.

Overdose Warning:

Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions: do not take more than directed (see overdose warning)

• adults and children 12 years and over:
  • take 2 caplets every 6 hours as needed.
  • do not take more than 8 caplets in 24 hours
  • do not use more than 10 days unless directed by a doctor
• children under 12 years:
  • do not use this adult product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information

• store between 20°- 25°C (68°- 77°F)
• do not use if the box is opened

Inactive Ingredients

Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol®

Questions or Comments?
Call 1-866-383-9908

Manufactured by:

Cispharma Inc
1212 Cranbury S River Road
Cranbury, NJ 08512

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52204-115
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (White)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	18mm
Flavor		Imprint Code	C;15
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52204-115-99	26549 in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/28/2011

Labeler - Cispharma, Inc (833171445)

Registrant - Cispharma, Inc (833171445)

Establishment
Name	Address	ID/FEI	Business Operations
Cispharma, Inc		833171445	manufacture