ACETAMINOPHEN ER- acetaminophen tablet, film coated, extended release 
DirectRX

----------

ACETAMINOPHEN ER


Drug Facts


Acetaminophen USP, 650 mg


Pain reliever/fever reducer


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

Liver warning

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


more than 6 caplets 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 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

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.

do not take more than directed (see overdose warning)

adults


take 2 caplets every 8 hours with water

swallow whole; do not crush, chew, split or dissolve

do not take more than 6 caplets in 24 hours

do not use for more than 10 days unless directed by a doctor

under 18 years of age


ask a doctor


store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).

see end panel for batch number and expiration date

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.


croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide


call 1-800-406-7984


Distributed by:
Ohm Laboratories Inc.
North Brunswick, NJ 0890


Keep out of reach of children.

860-71

ACETAMINOPHEN  ER
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-860(NDC:51660-333)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-860-71100 in 1 BOTTLE; Type 0: Not a Combination Product04/26/201910/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/26/201910/06/2023
Labeler - DirectRX (079254320)
Registrant - DirectRX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRX079254320relabel(61919-860)

Revised: 10/2023
 
DirectRX