MUCUS RELIEF COUGH AND CONGESTION DM- guaifenesin and dextromethorphan hbr tablet, 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 44-533-Delisted

Active ingredients (in each immediate-release tablet)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough suppressant
Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Do not use

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.

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

When using this product

do not use more than directed.

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

D&C yellow #10 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
cough &
congestion DM
dextromethorphan HBr 20 mg
guaifenesin 400 mg

cough suppressant
& expectorant

relieves cough and
chest congestion

thins and loosens mucus

ACTUAL SIZE

IMMEDIATE RELEASE
30 TABLETS

50844 REV0612B53301

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

IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

SATISFACTION GUARANTEE
RITE AID®

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

Rite Aid 44-533

MUCUS RELIEF COUGH AND CONGESTION DM
guaifenesin and dextromethorphan hbr tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-5330
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	YELLOW	Score	2 pieces
Shape	OVAL	Size	16mm
Flavor		Imprint Code	44;533
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-5330-0	1 in 1 CARTON	12/31/2005	10/04/2021
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:11822-5330-1	1 in 1 CARTON	12/31/2005	09/06/2021
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	12/31/2005	10/04/2021

Labeler - Rite Aid Corporation (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(11822-5330)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(11822-5330)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(11822-5330)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(11822-5330)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(11822-5330)

Revised: 1/2021

Document Id: f8311499-1180-498a-bc4f-2a1a61a20e6f

Set id: 1b7c1550-27d6-4892-af35-4da09f407e6b

Version: 13

Effective Time: 20210119

Rite Aid Corporation