MedPath

Mucus Relief

Drug Facts

Approved
Approval ID

de1258c1-a8d7-45a5-b099-39ceefcedc8d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Rite Aid Corporation

DUNS: 014578892

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Guaifenesin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11822-7329
Application NumberANDA207342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (10)

GUAIFENESINActive
Quantity: 1200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/20/2025

Package Label

![Guaifenesin 1200 mg](/dailymed/image.cfm?name=mucus-relief-1200-mg-extended- release-caplet-delis-1.jpg&id=894109)

RITE AID Maximum Strength Mucus Relief

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2025

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/20/2025

Inactive ingredients

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/20/2025

Questions or comments?

Call** 1-877-753-3935**Monday-Friday 9AM-5PM EST

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2025

Active ingredient (in each extended-release tablet)

Guaifenesin 1200 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2025

Purpose

Expectorant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2025

Warnings

Do not use

for children under 12 years of age.

Ask a doctor before use if you have

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

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 illness.

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2025

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/20/2025

Other information

  • store between 20º to 25ºC (68º to 77ºF)

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