MedPath

Mucus Relief

CVS Guaifenesin Extended-Release Tablets 1200 mg

Approved
Approval ID

2cfbb804-de2b-5b2f-e063-6394a90a0824

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

CVS Pharmacy

DUNS: 062312574

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 Code51316-724
Application NumberANDA217780
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (11)

GUAIFENESINActive
Quantity: 1200 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

724R CVS Guaifenesin tablets IFC

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2025

Uses

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/23/2025

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 5/23/2025

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/23/2025

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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/23/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/23/2025

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/23/2025

Purpose

Expectorant

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

Warnings

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/23/2025

Do not use

  • for children under 12 years of age

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/23/2025

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)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

Directions

  • do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
  • children under 12 years of age: do not use

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/23/2025

Other information

  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/23/2025

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