CURIST MUCUS RELIEF- guaifenesin tablet, extended release

Curist Mucus Relief by

Drug Labeling and Warnings

Curist Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Little Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each extended release tablet)

Guaifenesin 600 mg

PURPOSE

Purpose

Expectorant

INDICATIONS & USAGE

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

WARNINGS

Warnings

DO NOT USE

Do not use

• for children under 12 years of age

ASK DOCTOR

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

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

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

STORAGE AND HANDLING

Other information

• tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
• store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENT

Inactive ingredients carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS

Questions? 1-844-243-1241

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by:

Little Pharma, Inc.

New York, NY 10023

PRINCIPAL DISPLAY PANEL

curist

Mucus Relief

Guaifenesin Extended-Release Tablets 600 mg

Expectorant

12 Hour

Relieves Chest Congestion

Thins and Loosens Mucus

30 Extended Release Tablets

INGREDIENTS AND APPEARANCE

CURIST MUCUS RELIEF 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72559-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	G233
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72559-001-03	3 in 1 CARTON	06/05/2019
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209215	06/05/2019

Labeler - Little Pharma, Inc. (074328189)