Safrel Mucus Relief

Manufacturer: Safrel Pharmaceuticals, LLC.
Effective date: 2022-05-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:49:37

Label at a glance#

ProductSafrel Mucus Relief

Active ingredientGUAIFENESIN

Label structure12 sections

Storage and handling

Other information store between 20°-25°C (68°-77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-844-384-3723

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

for children under 12 years of age

OTC - ASK DOCTOR SECTION

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)

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 SECTION

Other information

store between 20°-25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.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

100 ct

500 Extended-Release Tablets

500 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
636522	guaiFENesin 600 MG 12HR Extended Release Oral Tablet	PSN	1
636522	12 HR guaifenesin 600 MG Extended Release Oral Tablet	SCD	1
636522	guaifenesin 600 MG 12 HR Extended Release Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71309-460-05	2024-01-30	C162847	48780-1	1030e365-12f2-111a-e063-dadaa90a10e2	Safrel Mucus Relief (Guaifenesin 600 mg) ER
71309-460-10	2024-01-30	C162847	48780-1	1030e365-12f2-111a-e063-dadaa90a10e2	Safrel Mucus Relief (Guaifenesin 600 mg) ER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71309-460-05	Safrel Mucus Relief	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500		1
71309-460-10	Safrel Mucus Relief	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71309-460	SAFREL MUCUS RELIEF (GUAIFENESIN) TABLET, EXTENDED RELEASE [SAFREL PHARMACEUTICALS, LLC.]	1	Legacy NDC, 2 package rows	20220519_df498e82-e1c8-51eb-e053-2a95a90a49b6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Safrel Mucus Relief
Guaifenesin
SODIUM STARCH GLYCOLATE TYPE A POTATO
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71309-460	71309-460-10, 71309-460-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)	K6MOM3T5YL	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
GUAIFENESIN	495W7451VQ	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213420-001	GUAIFENESIN	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL			2020-05-08
A213420-002	GUAIFENESIN	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL			2020-05-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213420-001	GUAIFENESIN	600MG	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213420-002	GUAIFENESIN	1.2GM	TABLET, EXTENDED RELEASE / ORAL	2020-05-08	`782e0a99824c…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
df498e8e-dc9b-41e1-e053-2a95a90a42c0			df498e82-e1c8-51eb-e053-2a95a90a49b6	2022-05-18	Warnings	Exact identifier spl id: df498e8e-dc9b-41e1-e053-2a95a90a42c0 spl set id: df498e82-e1c8-51eb-e053-2a95a90a49b6