ACETAMINOPHEN- acetaminophen tablet, film coated, extended release 
Amerisource Bergen

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Acetaminophen

Drug Facts

Active ingredient (in each caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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.

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over

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

children under 12 years

do not use

Other information

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.

Inactive ingredients

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

Questions?

call 1-800-406-7984

Distributed By:
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

GOOD
NEIGHBOR
PHARMACY®

Compare to Tylenol® 8 Hour
active ingredient

NDC 46122-062-71

Use only as directed.

Last up to
8 Hour
acetaminophen extended-release tablets USP, 650 mg

Pain Reliever/Fever Reducer

DO NOT USE WITH
OTHER MEDICINES
CONTAINING
ACETAMINOPHEN

50 caplets*

(*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton
ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-062
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSPOVIDONE (UNII: 2S7830E561)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule Shaped) Size19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-062-7150 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2002
2NDC:46122-062-78100 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/30/2002
Labeler - Amerisource Bergen (007914906)
Registrant - Ohm Laboratories Inc. (051565745)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(46122-062)

Revised: 7/2022
Document Id: d0ea1815-1f04-4c23-9761-307116c04b63
Set id: c0f4d7f1-aa17-4233-bc47-41c280fdd7ce
Version: 5
Effective Time: 20220707
 
Amerisource Bergen