FDA.reportPublic FDA data

Cough Relief

Manufacturer
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
Effective date
2021-10-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:33:56

Label at a glance#

ProductCough Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Dosage and administration

do not take more than 8 softgels in any 24-hour period this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: take 2 softgels every 6 to 8 hours, as needed children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 15 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, seek medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 8 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • adults and children 12 years and over: take 2 softgels every 6 to 8 hours, as needed
  • children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • store between 20-25ºC (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF); protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-33935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENT OF ROBITUSSIN® LONG-ACTING COUGHGELS®*

ADULT LONG LASTING

Cough Relief

• Dextromethorphan HBr, 15 mg

Cough Suppressant

Relieves cough for up to 8 hours, Non-Drowsy

AGES 12+

Softgels

This product is not manufactured or distributed by Pfizer Consumer Healthcare, Distributor of Robitussin® Long-Acting CoughGels®.

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

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED Cough Relief Softgels
ASSURED Cough Relief Softgels

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-066633992-0666-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
b2fc17a8-1922-4752-a52d-023afa8b5f15aaefda09-5379-4192-af38-a04cfc789c522021-10-07WarningsExact identifier
spl id: b2fc17a8-1922-4752-a52d-023afa8b5f15
spl set id: aaefda09-5379-4192-af38-a04cfc789c52

Reported adverse events (FAERS/openFDA)#

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