FDA.reportPublic FDA data

272R RITE AID 11822 7836 GUAIFENESIN 400 mg TABLETS

Manufacturer
RITE AID | TIME CAP LABORATORIES INC | MARKSANS PHARMA LTD.
Effective date
2021-12-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:08

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each immediate-release tablet)

Guaifenesin 400 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • persistant or chronic cough such as occurs with smoking , asthma, chronic bronchitis, or emphysema
  • cough accompanied by excessive phlegm (mucus)

OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dosage
  • do not use for more than 7 days

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a healthcare 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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
  • children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°- 86°F)
  • keep in a dry place and do not expose to excessive heat

INACTIVE INGREDIENT SECTION

Inactive ingredients colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

272R-Rite Aid-Mucus Relief-bottle label-30s272R-Rite Aid-Mucus Relief-bottle label-30s272R-Rite Aid-Mucus Relief-carton label-30s272R-Rite Aid-Mucus Relief-carton label-30s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN1
359601guaifenesin 400 MG Oral TabletSCD1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-7836-52025-01-30C16284748780-12cef2736-6f05-d83d-e063-dadaa90ab31f272R RITE AID 11822 7836 GUAIFENESIN 400 mg TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-7836-5Guaifenesin30 in 1 BOTTLETABLET301
11822-7836-5Guaifenesin1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7836GUAIFENESIN TABLET [RITE AID]1Legacy NDC, 2 package rows20211231_d1700952-d835-fa09-e053-2995a90ae617.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-783611822-7836-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
GUAIFENESIN495W7451VQACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
POVIDONEFZ989GH94EIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d1700952-d836-fa09-e053-2995a90ae617d1700952-d835-fa09-e053-2995a90ae6172021-12-24WarningsExact identifier
spl id: d1700952-d836-fa09-e053-2995a90ae617
spl set id: d1700952-d835-fa09-e053-2995a90ae617

Reported adverse events (FAERS/openFDA)#

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