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NDC 71335-1536-03 Acetaminophen 500 mg/1 Details

Acetaminophen 500 mg/1

Acetaminophen 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: 71335-1536-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	71335-1536
Product ID	71335-1536_77fb237f-28b5-486b-b9ef-cb324d5cc0bd
Associated GPIs	64200010000315
GCN Sequence Number	004490
GCN Sequence Number Description	acetaminophen TABLET 500 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16965
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
Route	ORAL
Active Ingredient Strength	500
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	2023-12-31

Package

Package Images

NDC 71335-1536-03 (71335153603)

Pricing Information	N/A
NDC Package Code	71335-1536-3
Billing NDC	71335153603
Package	40 TABLET in 1 BOTTLE (71335-1536-3)
Marketing Start Date	2022-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 77fb237f-28b5-486b-b9ef-cb324d5cc0bd Details

Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 500 mg

SPL UNCLASSIFIED SECTION

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

headache 
muscular aches 
backache 
minor pain of arthritis 
common cold 
toothache 
premenstrual and
menstrual cramps

SPL UNCLASSIFIED SECTION

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

more than 4,000 mg of acetaminophen in 24 hours
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.

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 tablets every 6 hours while symptoms last

• do not take more than 6 tablets in 24 hours, unless directed by a doctor

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

children under 12 years: ask a doctor

Other Information

store at room temperature

SPL UNCLASSIFIED SECTION

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

Call (800) 616-2471

SPL UNCLASSIFIED SECTION

SAVE CARTON FOR COMPLETE DRUG FACTS

Do not use if carton is open or if imprinted safety seal under cap is broken or missing.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

HOW SUPPLIED

NDC: 71335-1536-1: 20 Tablets in a BOTTLE

NDC: 71335-1536-2: 15 Tablets in a BOTTLE

NDC: 71335-1536-3: 40 Tablets in a BOTTLE

NDC: 71335-1536-4: 100 Tablets in a BOTTLE

NDC: 71335-1536-5: 30 Tablets in a BOTTLE

NDC: 71335-1536-6: 45 Tablets in a BOTTLE

NDC: 71335-1536-7: 50 Tablets in a BOTTLE

NDC: 71335-1536-8: 60 Tablets in a BOTTLE

NDC: 71335-1536-9: 90 Tablets in a BOTTLE

NDC: 71335-1536-0: 250 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Acetaminophen 500mg Tablet

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-1536(NDC:0904-6730)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	54;27
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-1536-1	20 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
2	NDC:71335-1536-2	15 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
3	NDC:71335-1536-3	40 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
4	NDC:71335-1536-4	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/17/2020
5	NDC:71335-1536-5	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2020
6	NDC:71335-1536-6	45 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
7	NDC:71335-1536-7	50 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
8	NDC:71335-1536-8	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
9	NDC:71335-1536-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022
10	NDC:71335-1536-0	250 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	09/12/2018

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-1536) , RELABEL(71335-1536)

Revised: 2/2022

Document Id: 77fb237f-28b5-486b-b9ef-cb324d5cc0bd

Set id: 77fb237f-28b5-486b-b9ef-cb324d5cc0bd

Version: 2

Effective Time: 20220214

Search by Drug Name or NDC

NDC 71335-1536-03 Acetaminophen 500 mg/1 Details

Acetaminophen 500 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71335-1536-03 (71335153603)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 77fb237f-28b5-486b-b9ef-cb324d5cc0bd Details

Drug Facts

SPL UNCLASSIFIED SECTION

Uses

SPL UNCLASSIFIED SECTION

Directions

Other Information

SPL UNCLASSIFIED SECTION

Questions or comments?

SPL UNCLASSIFIED SECTION

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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