MUCUS RELIEF- guaifenesin tablet

MUCUS RELIEF by

Drug Labeling and Warnings

MUCUS RELIEF by is a Otc medication manufactured, distributed, or labeled by SDA Laboratories, Inc., Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

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

Warnings

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 excessive phlegm (mucus)

Stop use and ask a doctor if

cough lasts more than 7 days or comes back
cough 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.

Directions

• take with full glass of water
• not intended for use in children under 12 years of age

• Adults and children 12 years of age and over:
  • take 1 caplet, every 4 hours, while ; symptoms persist
  • do not exceed 6 doses in 24 hours
• Children under 12 years of age: do not use

Other information

Tamper Evident:do not use if imprinted safety seal under cap is broken or missing.

store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients:

cellulose, magnesium stearate, maltodextrin, povidone, silica, stearic acid.

Questions or comments?

1-203-861-0005

SPL UNCLASSIFIED SECTION

Manufactured for:

SDA Laboratories, Inc.

New York, NY

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MUCUS RELIEF 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66424-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	AP;152
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66424-001-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2025

Labeler - SDA Laboratories, Inc. (948067889)

Registrant - SDA Laboratories, Inc. (948067889)

Establishment
Name	Address	ID/FEI	Business Operations
Geri-Care Pharmaceutical Corp		611196254	manufacture(66424-001)