Guaifenesin 1200 mg

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Guaifenesin 1200 mg
Generic name: GUAIFENESIN
Manufacturer: Dr. Reddy's Laboratories Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 525fda90-134c-f038-c403-eb5ffc1fb1f1
SPL ID: ef6a6eb4-cde7-cd56-0290-29d56beec22c
Version: 4
Effective date: 2025-09-22
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:47:19

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	215932	derived:openfda.application_number
application number		ANDA215932	openfda.application_number
brand name		Guaifenesin 1200 mg	openfda.brand_name
brand name		Guaifenesin 600 mg	openfda.brand_name
generic name		GUAIFENESIN	openfda.generic_name
manufacturer name		Dr. Reddy's Laboratories Inc.	openfda.manufacturer_name
ndc	package	43598-110-01	openfda.package_ndc
ndc	package	43598-108-37	openfda.package_ndc
ndc	product	43598-110	openfda.product_ndc
ndc	product	43598-108	openfda.product_ndc
ndc11	package	43598011001	derived:openfda.package_ndc
ndc11	package	43598010837	derived:openfda.package_ndc
rxcui		636522	openfda.rxcui
rxcui		310621	openfda.rxcui
spl id		ef6a6eb4-cde7-cd56-0290-29d56beec22c	id
spl set id		525fda90-134c-f038-c403-eb5ffc1fb1f1	set_id
unii		495W7451VQ	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Applicable warning(s) in 201.66(c)(5)(i) and (ii) Do not use For children under 12 years age Ask a doctor before use if 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 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 Pregnancy/Breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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