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NDC 00363-0340-08 Acetaminophen 650 mg/1 Details

Acetaminophen 650 mg/1

Acetaminophen is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-0340-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00363-0340
Product ID	0363-0340_1bc5ce72-38f4-43f7-99cc-2b8b4725e15b
Associated GPIs	64200010001840
GCN Sequence Number	002706
GCN Sequence Number Description	mag hydrox/aluminum hyd/simeth ORAL SUSP 400-400-40 ORAL
HIC3	D4B
HIC3 Description	ANTACIDS
GCN	63915
HICL Sequence Number	001168
HICL Sequence Number Description	MAGNESIUM HYDROXIDE/ALUMINUM HYDROXIDE/SIMETHICONE
Brand/Generic	Generic
Proprietary Name	Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Walgreen Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078569
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0340-08 (00363034008)

Pricing Information	N/A
NDC Package Code	0363-0340-08
Billing NDC	00363034008
Package	80 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-0340-08)
Marketing Start Date	2016-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a1cec332-5802-4684-8b7f-6cb98da40e8b Details

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

PRINCIPAL DISPLAY PANEL - 650 mg Geltab Bottle Label

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

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)
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

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

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

Labeler - Walgreen Company (008965063)

Registrant - Ranbaxy Pharmaceuticals Inc. (947890044)

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

Revised: 8/2018

Document Id: 1bc5ce72-38f4-43f7-99cc-2b8b4725e15b

Set id: a1cec332-5802-4684-8b7f-6cb98da40e8b

Version: 4

Effective Time: 20180815

Search by Drug Name or NDC

NDC 00363-0340-08 Acetaminophen 650 mg/1 Details

Acetaminophen 650 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00363-0340-08 (00363034008)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a1cec332-5802-4684-8b7f-6cb98da40e8b Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each geltab)

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 - 650 mg Geltab Bottle Label

INGREDIENTS AND APPEARANCE

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