Guaifenesin Tablets 400 mg

Manufacturer
APNAR PHARMA LP | Apnar Pharma Private Limited | APNAR PHARMA LLP
Effective date
2023-01-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:41:26

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure12 sections

Boxed warning

Caution: do not use if imprinted seal under cap is broken or missing.

Storage and handling

Other Information store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

BOXED WARNING SECTION

Caution: do not use if imprinted seal under cap is broken or missing.

OTC - ACTIVE INGREDIENT SECTION

Drug Facts
Active Ingredient (per tablet)
Guaifenesin USP............. 400 mg

OTC - PURPOSE SECTION

Purpose
Expectorant

INDICATIONS & USAGE SECTION

Use

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

WARNINGS SECTION

Warnings


Ask doctor before use if you have

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

Stop use and ask a doctor if

  • Symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur
  • A persistent cough may be a sign of a serious condition

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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

STORAGE AND HANDLING SECTION

Other Information

  • store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Microcrystalline cellulose, Croscarmellose sodium, Povidone, Silicon dioxide, magnesium stearate

OTC - QUESTIONS SECTION

Questions or concerns?

  • 1-855-642-2594

SPL UNCLASSIFIED SECTION

Distributed by:

APNAR PHARMA LP

CHINO, CA, 91710

Rev.: 04/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

APNAR PHARMA LP

NDC : 24689-122-01

Guaifenesin Tablets 400mg-20's Tablets

Guaifenesin Tablets 400mg_20s TabletsGuaifenesin Tablets 400mg_20s Tablets

APNAR PHARMA LP

NDC : 24689-122-02

Guaifenesin Tablets 400mg-500's Tablets

Guaifenesin Tablets 400mg_500sGuaifenesin Tablets 400mg_500s

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24689-122-012025-02-01C16284748780-12cef2736-8218-d83d-e063-dadaa90ab31fGuaifenesin Tablets 400 mg
24689-122-022025-02-01C16284748780-12cef2736-8218-d83d-e063-dadaa90ab31fGuaifenesin Tablets 400 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-122-01EA - Each24689-122a0851bd0-5484-4880-9b3b-694b2ddf01ff12023-02-06
24689-122-02EA - Each24689-1221d208621-69b0-4dfb-98da-2c7bb3d6c04612023-02-06

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24689-12224689-122-01, 24689-122-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
45d2f472-0372-f59c-e063-6394a90ab537e217672e-ba0a-e79e-e053-2a95a90a6cd12025-12-13Boxed warning, WarningsExact identifier
spl set id: e217672e-ba0a-e79e-e053-2a95a90a6cd1

Reported adverse events (FAERS/openFDA)#

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