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NDC 71335-1398-05 Plus Pharma 325 mg/1 Details

Plus Pharma 325 mg/1

Plus Pharma is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 71335-1398-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	71335-1398
Product ID	71335-1398_471a68b8-f1a6-4c80-b06a-2fbbbd6a0b62
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Plus Pharma
Proprietary Name Suffix	Pain Reliever,Fever Reducer
Non-Proprietary Name	ACETAMINOPHEN
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	325
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71335-1398-05 (71335139805)

Pricing Information	N/A
NDC Package Code	71335-1398-5
Billing NDC	71335139805
Package	6 TABLET in 1 BOTTLE (71335-1398-5)
Marketing Start Date	2006-03-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 19a9094a-e1db-4e5f-b39a-45c66f739f93 Details

SPL UNCLASSIFIED SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Acetaminophen 325 mg

SPL UNCLASSIFIED SECTION

Purposes

Pain reliever/fever reducer

SPL UNCLASSIFIED SECTION

Uses

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

SPL UNCLASSIFIED SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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 non prescription). 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 the user has liver disease.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
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: Taking more than the recommended dose (overdose) may cause liver damage. 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.

SPL UNCLASSIFIED SECTION

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years	take 1 tablet every 4 to 6 hours, while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

SPL UNCLASSIFIED SECTION

Other information

store at room temperature in a dry place

SPL UNCLASSIFIED SECTION

Inactive ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

SPL UNCLASSIFIED SECTION

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

SPL UNCLASSIFIED SECTION

Distributed by: Plus Pharma, Commack, NY 11725

Manufactured in a GMP facility in the USA

HOW SUPPLIED

Product: 71335-1398

NDC: 71335-1398-0 24 TABLET in a BOTTLE

NDC: 71335-1398-1 20 TABLET in a BOTTLE

NDC: 71335-1398-2 100 TABLET in a BOTTLE

NDC: 71335-1398-3 30 TABLET in a BOTTLE

NDC: 71335-1398-4 2 TABLET in a BOTTLE

NDC: 71335-1398-5 6 TABLET in a BOTTLE

NDC: 71335-1398-6 10 TABLET in a BOTTLE

NDC: 71335-1398-7 60 TABLET in a BOTTLE

NDC: 71335-1398-8 90 TABLET in a BOTTLE

NDC: 71335-1398-9 40 TABLET in a BOTTLE

Acetaminophen 325 mg. Tablet

INGREDIENTS AND APPEARANCE

PLUS PHARMA PAIN RELIEVER,FEVER REDUCER

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-1398(NDC:51645-703)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (round)	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	10mm
Flavor		Imprint Code	GPI;A325
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-1398-4	2 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006
2	NDC:71335-1398-7	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006
3	NDC:71335-1398-6	10 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006
4	NDC:71335-1398-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006
5	NDC:71335-1398-5	6 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006
6	NDC:71335-1398-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006
7	NDC:71335-1398-0	24 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006
8	NDC:71335-1398-9	40 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006
9	NDC:71335-1398-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006
10	NDC:71335-1398-8	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/27/2006

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-1398) , RELABEL(71335-1398)

Revised: 1/2020

Document Id: 471a68b8-f1a6-4c80-b06a-2fbbbd6a0b62

Set id: 19a9094a-e1db-4e5f-b39a-45c66f739f93

Version: 2

Effective Time: 20200119

Search by Drug Name or NDC

NDC 71335-1398-05 Plus Pharma 325 mg/1 Details

Plus Pharma 325 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71335-1398-05 (71335139805)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 19a9094a-e1db-4e5f-b39a-45c66f739f93 Details

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HOW SUPPLIED

Acetaminophen 325 mg. Tablet

INGREDIENTS AND APPEARANCE

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