CHEST CONGESTION RELIEF- guaifenesin tablet, film coated

Chest Congestion Relief by

Drug Labeling and Warnings

Chest Congestion Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

INGREDIENTS AND APPEARANCE

CHEST CONGESTION RELIEF 
guaifenesin tablet, film coated

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

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	44;532
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0452-2	2 in 1 CARTON	03/15/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 70000-0452-1	1 in 1 CARTON	03/15/2019
2		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/15/2019

Labeler - Cardinal Health (097537435)

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

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

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

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

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