CVS Childrens Cough Relief

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: CVS Childrens Cough Relief
Generic name: DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN
Manufacturer: CVS PHARMACY, INC
Product type: HUMAN OTC DRUG
SPL set ID: fe12f3bd-3237-42d1-aec5-c831b9637175
SPL ID: 4ce33b05-0044-4e78-9d09-bfe66c3b79e5
Version: 6
Effective date: 2026-08-19
Source export date: 2026-10-30
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/a3e33fe073aa0aa94eb690c6684c74434c63cebfbf7c5530205a2c3e957ecb8b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:45:48

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		CVS Childrens Cough Relief	openfda.brand_name
generic name		DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	openfda.generic_name
manufacturer name		CVS PHARMACY, INC	openfda.manufacturer_name
ndc	package	69842-577-04	openfda.package_ndc
ndc	product	69842-577	openfda.product_ndc
ndc11	package	69842057704	derived:openfda.package_ndc
rxcui		1020138	openfda.rxcui
spl id		4ce33b05-0044-4e78-9d09-bfe66c3b79e5	id
spl set id		fe12f3bd-3237-42d1-aec5-c831b9637175	set_id
unii		9D2RTI9KYH	openfda.unii
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 Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has • cough that occurs with too much phlegm (mucus) • persistent or chronic cough such as occurs with asthma 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 condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Reported adverse events (FAERS/openFDA)#

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