ACETAMINOPHEN tablet, extended release

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each geltab)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • minor pain of arthritis
  • muscular aches
  • backache
  • premenstrual and menstrual cramps
  • the common cold
  • headache
  • toothache
• temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 6 geltabs in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
• if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present
• the tablet got stuck in your throat

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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:
  • take 2 geltabs every 8 hours. Swallow only one geltab at a time.
  • take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 geltabs in 24 hours
  • do not use for more than 10 days unless directed by a doctor
• under 18 years of age:
  • ask a doctor

Other information

• store at 20 - 25° C (68 - 77° F). Avoid high humidity.
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch (corn), titanium dioxide

Questions?

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 650 mg Geltab Bottle Label

Walgreens

Compare to Tylenol® 8 HR
Arthritis Pain active ingredient††

EASY-OPEN

NDC: 0363-0340-08

Arthritis Pain Reliever
ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP,
650 mg / PAIN RELIEVER / FEVER REDUCER

ARTHRITIS 8 HOUR

• For the temporary relief of minor arthritis pain
• Lasts up to 8 hours

ACTUAL SIZE

80 GELTABS* (*GELATIN-COATED TABLETS)

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0340
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (White to Yellow)	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	350
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0340-08	80 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078569	05/01/2016

Labeler - Walgreen Company (008965063)

Registrant - Ranbaxy Pharmaceuticals Inc. (947890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		184769029	MANUFACTURE(0363-0340)