SAFREL MUCUS RELIEF- guaifenesin tablet, extended release

Safrel Mucus Relief by

Drug Labeling and Warnings

Safrel Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Safrel Pharmaceuticals, LLC.. 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

• 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

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

• store between 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

Inactive ingredients carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

QUESTIONS

Questions or comments?

Call 1-844-384-3723

SPL UNCLASSIFIED SECTION

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

Safrel Pharmaceuticals, LLC

Bridgewater, NJ 08807

Made in India

PRINCIPAL DISPLAY PANEL

Safrel Mucus Relief

Guaifenesin Extended-Release Tablets 600 mg

Expectorant

12 Hour

Relieves Chest Congestion

Thins and Loosens Mucus

Immediate and Extended Release

100 Extended-Release Tablets

500 Extended-Release Tablets

INGREDIENTS AND APPEARANCE

SAFREL MUCUS RELIEF 
guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71309-460
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
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	G;600
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71309-460-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/21/2022
2	NDC: 71309-460-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213420	02/21/2022

Labeler - Safrel Pharmaceuticals, LLC. (080566287)