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NDC 63868-0091-50 Acetaminophen 650 mg/1 Details

Acetaminophen 650 mg/1

Acetaminophen is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association Inc.. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 63868-0091-50
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	63868-0091
Product ID	63868-091_76aae029-5743-4cb2-b497-136c941443ea
Associated GPIs	64200010000420
GCN Sequence Number	022123
GCN Sequence Number Description	acetaminophen TABLET ER 650 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16910
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Chain Drug Marketing Association Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076200
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0091-50 (63868009150)

Pricing Information	N/A
NDC Package Code	63868-091-50
Billing NDC	63868009150
Package	50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63868-091-50)
Marketing Start Date	2002-04-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ded10c13-8a4e-469d-8b34-0d6566be016c Details

SPL UNCLASSIFIED SECTION

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

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

Questions?

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

NDC 63868-091-50

QUALITY

CHOICE

†Compare to

Active Ingredient in

TYLENOL® 8 Hour

Last up to 8 Hours | Use Only as Directed

8 Hour Pain Relief

Acetaminophen Extended-release Tablets USP, 650 mg

Pain Reliever | Fever Reducer

For up to 8 Hours Relief of Minor Muscle Aches & Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

50 CAPLETS* (*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-091
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
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)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Capsule Shaped)	Size	19mm
Flavor		Imprint Code	cor116
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-091-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2002
2	NDC:63868-091-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076200	04/30/2002

Labeler - Chain Drug Marketing Association Inc. (011920774)

Registrant - Sun Pharmaceutical Industries Inc. (146974886)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	manufacture(63868-091)

Revised: 12/2019

Document Id: 76aae029-5743-4cb2-b497-136c941443ea

Set id: ded10c13-8a4e-469d-8b34-0d6566be016c

Version: 2

Effective Time: 20191230

Search by Drug Name or NDC

NDC 63868-0091-50 Acetaminophen 650 mg/1 Details

Acetaminophen 650 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 63868-0091-50 (63868009150)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ded10c13-8a4e-469d-8b34-0d6566be016c Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each caplet)

Purpose

Uses

Warnings

Liver warning

Do not use

Stop use and ask a doctor if

Overdose warning

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 50 Caplet Bottle Carton

INGREDIENTS AND APPEARANCE

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