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NDC 70000-0306-01 Leader 8 HR Muscle Aches and Pain 650 mg/1 Details

Leader 8 HR Muscle Aches and Pain 650 mg/1

Leader 8 HR Muscle Aches and Pain is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. 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: 70000-0306-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	70000-0306
Product ID	70000-0306_da4f44f4-a384-4d41-9a0b-d2aad94db013
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	Leader 8 HR Muscle Aches and Pain
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	Cardinal Health 110, LLC. dba Leader
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075077
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0306-01 (70000030601)

Pricing Information
NDC Package Code	70000-0306-1
Billing NDC	70000030601
Package	1 BOTTLE in 1 CARTON (70000-0306-1) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date	2017-05-05
NDC Exclude Flag	N
Price Per Unit	0.06921
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	8HR MUSCLE ACHE-PAIN ER 650 MG
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL cf6e226f-459d-458d-b8cf-2051e7d8a52c Details

Active ingredient (in each caplet)

Acetaminophen 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)
•: do not use if printed foil under cap is broken or missing
•: meets the requirements of USP Dissolution Test 2

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

8HR Muscle Aches & Pain

Acetaminophen Extended-Release Tablets, 650 mg

Pain Reliever / Fever Reducer

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

100 CAPLETS*

650 mg EACH * Capsule-Shaped Tablets

Actual Size

COMPARE TO TYLENOL® 8HR

active ingredient

100% Money Back Guarantee

INGREDIENTS AND APPEARANCE

LEADER 8 HR MUSCLE ACHES AND PAIN

acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0306
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L544
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0306-1	1 in 1 CARTON	05/05/2017
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075077	05/05/2017

Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 6/2021

Document Id: da4f44f4-a384-4d41-9a0b-d2aad94db013

Set id: cf6e226f-459d-458d-b8cf-2051e7d8a52c

Version: 4

Effective Time: 20210617