CHEST CONGESTION RELIEF- guaifenesin tablet, film coated
Cardinal Health 110, LLC. DBA Leader

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader 44-532 Delisted

Active ingredient (in each immediate-release tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

cough accompanied by too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

take with a full glass of water
adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use

Other information

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

Inactive ingredients

FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal display panel

LEADER™

NDC 70000-0452-2

Chest Congestion Relief
Guaifenesin, 400 mg | Expectorant

Relieves Chest Congestion
Thins and Loosens Mucus

24 IMMEDIATE-RELEASE TABLETS

Actual Size

100% Money Back Guarantee

50844 ORG011853208

© 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
the Cardinal Health LOGO, LEADER, and the Leader LOGO are
trademarks or registered trademarks of Cardinal Health.

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Essential to Care™ since 1979

All LEADER™ Brand Products Have A
100% Money Back Guarantee

Return to place of purchase if not satisfied.

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

Leader 44-532

CHEST CONGESTION RELIEF
guaifenesin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0452
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	blue	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	44;532
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0452-2	3 in 1 CARTON	03/15/2019	09/21/2023
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:70000-0452-1	1 in 1 CARTON	03/15/2019	03/23/2022
2		60 in 1 BOTTLE, PLASTIC; 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	03/15/2019	09/21/2023

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

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(70000-0452)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(70000-0452)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(70000-0452)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(70000-0452)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(70000-0452)

Revised: 7/2022

Document Id: 6148c103-0b27-4a21-99a5-6f13694f432a

Set id: 92181899-0781-4008-8711-ac722695348f

Version: 8

Effective Time: 20220714

Cardinal Health 110, LLC. DBA Leader