MUCUS RELIEF by Geri-Care Pharmaceuticals, Corp gc 794au (614)

MUCUS RELIEF by

Drug Labeling and Warnings

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

Drug Details [pdf]

MUCUS RELIEF- guaifenesin tablet 
Geri-Care Pharmaceuticals, Corp

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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gc 794au (614)

Active ingredient (in each tablet)

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
  
• do not exceed recommended dose

• adults and children 12 years of age and over: 1 tablet, 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 20°-25°C (68°-77°F); excursions permitted between 15°C- 30°C (59°F - 86°F)

Inactive ingredients

maltodextrin, povidone, silica, stearic acid

Questions or comments?

1-800-540-3765

package Label

MUCUS RELIEF 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-614
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
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (white to off white)	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code	AG1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-614-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021
2	NDC: 57896-614-06	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/01/2021	11/30/2023

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Registrant - Geri-Care Pharmaceuticals, Corp (611196254)

Revised: 11/2022

Document Id: ee13ae41-86e0-12f7-e053-2a95a90a2a13

34390-5

Set id: d218f365-6f48-5639-e053-2995a90a10a9

Version: 2

Effective Time: 20221122