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foster and thrive mucus relief

McKesson Mucus Relief Drug Facts

Approved
Approval ID

b875dc68-931c-4329-ab61-83347884aaeb

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Strategic Sourcing Services LLC

DUNS: 116956644

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 Code70677-1291
Application NumberANDA078912
Product Classification
M
Marketing Category
C73584
G
Generic Name
guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (7)

GUAIFENESINActive
Quantity: 600 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)Inactive
Code: K6MOM3T5YL
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

Package/Label Principal Display Panel

COMPARE TO MUCINEX® EXTENDED RELEASE TABLETS 600 mg ACTIVE INGREDIENT

Foster & Thrive™

REGULAR STRENGTH

Mucus Relief

Guaifenesin Extended-Release Tablets, 600 mg

EXPECTORANT

12 Hour

• Relieves Chest Congestion

• Thins & Loosens Mucus

• Immediate and Extended Release

Gluten Free

ACTUAL SIZE

100 EXTENDED-RELEASE TABLETS

foster&thrive-mucus-relief-carton- image.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/17/2025

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/17/2025

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/17/2025

Purpose

Expectorant

WARNINGS SECTION

LOINC: 34071-1Updated: 4/17/2025

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: 4/17/2025

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 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.

children under 12 years of age: do not use

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/21/2025

Other information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/17/2025

Inactive ingredients

carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/21/2025

Questions or comments?

Call833-358-6431 Monday to Friday 9:00am to 7:00pm EST

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foster and thrive mucus relief - FDA Drug Approval Details