MUCUS RELIEF CHEST CONGESTION- guaifenesin tablet, film coated
Rite Aid Corporation

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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Rite Aid 44-532

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 or bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

cough that occurs with 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 lasts more than 7 days, comes back, or occurs with 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 right away.

Directions

take with a full glass of water
adults and children 12 years of age 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

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
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

RITE AID®
PHARMACY

mucus relief
chest
congestion
guaifenesin 400 mg
expectorant

relieves chest congestion
thins and loosens mucus

ACTUAL SIZE

IMMEDIATE RELEASE
30 TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0812A53201

DISTRIBUTED BY:RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011

Rite Aid 44-532

MUCUS RELIEF CHEST CONGESTION
guaifenesin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0532
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 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

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:11822-0532-3	1 in 1 CARTON	12/22/2005	12/12/2015
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11822-0532-0	1 in 1 CARTON	12/22/2005	07/22/2016
2		60 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:11822-0532-1	1 in 1 CARTON	12/22/2005	08/27/2021
3		30 in 1 BOTTLE; 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	12/22/2005	08/27/2021

Labeler - Rite Aid Corporation (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(11822-0532)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(11822-0532)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(11822-0532)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(11822-0532)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(11822-0532)

Revised: 1/2021

Document Id: a0ca33e7-afb9-46e6-8c1c-ee7d1efb0e08

Set id: 42f66a80-41d1-4ff6-adda-924178bf2a9e

Version: 12

Effective Time: 20210119

Rite Aid Corporation