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NDC 70000-0196-01 Sinus Congestion and Pain Severe 325; 200; 5 mg/1; mg/1; mg/1 Details

Sinus Congestion and Pain Severe 325; 200; 5 mg/1; mg/1; mg/1

Sinus Congestion and Pain Severe is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. DBA Leader. The primary component is ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

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: 70000-0196-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 70000-0196-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 70000-0196-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	70000-0196
Product ID	70000-0196_50d37b80-c82f-41e7-8929-f57411491bc0
Associated GPIs	43996703500310
GCN Sequence Number	060554
GCN Sequence Number Description	guaifen/phenyleph/acetaminophn TABLET 200-5-325 ORAL
HIC3	B3N
HIC3 Description	DECONGESTANT-ANALGESIC-EXPECTORANT COMBINATION
GCN	26743
HICL Sequence Number	023719
HICL Sequence Number Description	GUAIFENESIN/PHENYLEPHRINE HCL/ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Sinus Congestion and Pain Severe
Proprietary Name Suffix	Daytime,Non-Drowsy
Non-Proprietary Name	Acetaminophen, Guaifenesin, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	325; 200; 5
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Cardinal Health 110, LLC. DBA Leader
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 70000-0196-01 (70000019601)

Pricing Information
NDC Package Code	70000-0196-1
Billing NDC	70000019601
Package	2 BLISTER PACK in 1 CARTON (70000-0196-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2005-08-06
NDC Exclude Flag	N
Price Per Unit	0.10704
Pricing Unit	EA
Effective Date	2022-10-19
NDC Description	SINUS CONGST-PAIN 325-200-5 MG
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4
Classification for Rate Setting	G
As of Date	2022-11-23

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 b42316a2-45dc-4792-af3c-05eab06470fe Details

Active ingredients (in each caplet)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Expectorant

Nasal decongestant

Uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:

headache
nasal congestion
minor aches and pains
sinus congestion and pressure

temporarily reduces fever
helps loosen phlegm (mucus) and the bronchial secretions to make coughs more productive

Warnings

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:

blisters
rash
skin reddening

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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
high blood pressure
heart disease
diabetes
thyroid disease
liver disease
difficulty in urination due to enlargement of the prostate gland
cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. 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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
adults and children 12 years and over

take 2 caplets every 4 hours
swallow whole - do not crush, chew, or dissolve
do not take more than 10 caplets in 24 hours

children under 12 years: ask a doctor

Other information

see end flap for expiration date and lot number
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

LEADER™

NDC 70000-0196-1

Daytime ι Non-Drowsy

Sinus

Congestion & Pain Severe

Acetaminophen ι Guaifenesin ι Phenylephrine HCl

Pain Reliever/Fever Reducer ι Expectorant ι Nasal Decongestant

Sinus Headache,

Nasal Congestion, Sinus Pressure,

Chest Congestion, Mucus

24 CAPLETS

ACTUAL SIZE

COMPARE TO TYLENOL® SINUS SEVERE

active ingredients*

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY

SIGNS OF TAMPERING

CIN 5298153 REV. 11/17

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS SEVERE.

50844 REV0917A52708

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Essential to Care™ since 1979

CARDINAL HEALTH, the Cardinal Health LOGO

LEADER, and the Leader LOGO are trademarks or

registered trademarks of Cardinal Health.

CardinalHealth™

All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

Leader 44-527

INGREDIENTS AND APPEARANCE

SINUS CONGESTION AND PAIN SEVERE DAYTIME,NON-DROWSY

acetaminophen, guaifenesin, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0196
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	19mm
Flavor	MINT	Imprint Code	44;527
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0196-1	2 in 1 CARTON	08/06/2005	08/27/2023
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/06/2005	08/27/2023

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

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(70000-0196)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(70000-0196)

Revised: 4/2022

Document Id: 50d37b80-c82f-41e7-8929-f57411491bc0

Set id: b42316a2-45dc-4792-af3c-05eab06470fe

Version: 9

Effective Time: 20220406