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NDC 71205-0478-30 Pharbetol 500 mg/1 Details

Pharbetol 500 mg/1

Pharbetol is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 71205-0478-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	71205-0478
Product ID	71205-478_76bf2e05-8a22-48ff-9180-c582601932d2
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	Pharbetol
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	Proficient Rx LP
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 71205-0478-30 (71205047830)

Pricing Information	N/A
NDC Package Code	71205-478-30
Billing NDC	71205047830
Package	30 TABLET in 1 BOTTLE, PLASTIC (71205-478-30)
Marketing Start Date	2020-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 51ba690e-d76b-41c6-a083-8bc803e1faa2 Details

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

•: more than 8 tablets 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)

Directions

•: do not take more than directed (see overdose warning).

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

Other information

•: Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
•: store between 20-250C (68-770F)

Inactive ingredients

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions?

Adverse drug event call: 1-866-562-2756 Mon - Fri: 8 AM to 4 PM

PRINCIPAL DISPLAY PANEL

Repackaged By:

Proficient Rx LP

Thousand Oaks, CA 91320

NDC 71205-478-50

manufactured in the USA

Extra Strength *Compare to the active ingredient in Extra Strength Tylenol® Caplet

Do not use with any other product containing acetaminophen

PHARBETOL

Acetaminophen 500mg

Pain Reliever • Fever Reducer

50 TABLETS

INGREDIENTS AND APPEARANCE

PHARBETOL

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-478(NDC:16103-376)
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	PH044
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-478-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020
2	NDC:71205-478-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020
3	NDC:71205-478-40	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2020
4	NDC:71205-478-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2020
5	NDC:71205-478-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020
6	NDC:71205-478-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	01/10/2006

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-478) , RELABEL(71205-478)

Revised: 5/2022

Document Id: 76bf2e05-8a22-48ff-9180-c582601932d2

Set id: 51ba690e-d76b-41c6-a083-8bc803e1faa2

Version: 4

Effective Time: 20220502