Guaifenesin

Manufacturer
Bryant Ranch Prepack
Effective date
2025-03-31
Label type
HUMAN OTC DRUG LABEL
Version
102
Source
full-release
Hydrated at
2026-06-01 00:58:26

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure14 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in any 24- hour period this product is not intended for use in children under 12 years of age adults & children 12 years and over: 1 caplet every 4 hours children under 12 years: do not use

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS 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)

Stop use and ask a doctor if cough lasts more then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.

OTC - STOP USE SECTION

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in any 24- hour period
  • this product is not intended for use in children under 12 years of age
  • adults & children 12 years and over: 1 caplet every 4 hours
  • children under 12 years: do not use

Other information

SPL UNCLASSIFIED SECTION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, magnesium stearate, maltodextrin, microsrystalline cellulose, providone, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday

SPL UNCLASSIFIED SECTION

Drug Facts continued on back of label

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Reliable-1 Laboratoreis LLC

Valley Stream, Ny 11580 www.reliable1labs.com

HOW SUPPLIED

How Supplied Section

Guaifenesin 400 mg

NDC: 71335-9616-1: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-2: 20 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-3: 50 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-4: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-9616-5: 40 Tablets in a BOTTLE, PLASTIC

Store at 15°-30°C (59°-86°F)

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin 400 mg Tablet

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN102
359601guaifenesin 400 MG Oral TabletSCD102

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9616-1Guaifenesin30 in 1 BOTTLE, PLASTICTABLET30102
71335-9616-2Guaifenesin20 in 1 BOTTLE, PLASTICTABLET20102
71335-9616-3Guaifenesin50 in 1 BOTTLE, PLASTICTABLET50102
71335-9616-4Guaifenesin60 in 1 BOTTLE, PLASTICTABLET60102
71335-9616-5Guaifenesin40 in 1 BOTTLE, PLASTICTABLET40102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9616GUAIFENESIN TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20250403_570a71eb-2d19-4c7b-8c00-e1524bfa3844.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-061-06EA - Each69618-0619467aaf0-ae81-4301-a553-1077f9182d4412021-03-02

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-961671335-9616-1, 71335-9616-2, 71335-9616-3, 71335-9616-4, 71335-9616-5
69618-061

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuaifenesinGUAIFENESINBryant Ranch Prepack570a71eb-2d19-4c7b-8c00-e1524bfa38442025-03-31WarningsExact identifier
ndc (package): 71335-9616-5
ndc (package): 71335-9616-1
ndc (package): 71335-9616-3
ndc (package): 71335-9616-4
ndc (package): 71335-9616-2
ndc (product): 71335-9616
ndc11 (package): 71335961602
ndc11 (package): 71335961605
ndc11 (package): 71335961603
ndc11 (package): 71335961604
ndc11 (package): 71335961601
spl id: 97d545be-a78d-48b5-b774-ded0e82d742f
spl set id: 570a71eb-2d19-4c7b-8c00-e1524bfa3844
GuaifenesinGUAIFENESINReliable 1 Laboratories LLCae469d4f-91c4-cff0-e053-2995a90a04972025-01-15WarningsExact identifier
ndc (product): 69618-061

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.