FDA.reportPublic FDA data

Tussin Cough Gels

Manufacturer
Discount Drug Mart | LNK International, Inc.
Effective date
2021-05-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:45:01

Label at a glance#

ProductTussin Cough Gels
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections

Dosage and administration

do not take more than 8 capsules 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 capsules every 6 to 8 hours, as needed children under 12 years: do not use

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive heat above 40°C (104°F) protect from light see bottle for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 15 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Use

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

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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 out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 8 capsules 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 capsules every 6 to 8 hours, as needed
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light
  • see bottle for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-800- 426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT
drug
mart
FOOD FAIR

NDC 53943-661-09

LONG-ACTING
Tussin Cough Gels

Dextromethorphan HBr, USP 15 mg
Cough Suppressant

*Compare to the active ingredient in
Robitussin® CoughGels®

Actual Size

For Ages
12 & Over

Non-drowsy

Non-narcotic
Formula

20
LIQUIDGELS
Liquid-filled
Capsules

8 hr
Cough
Relief

SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED
PORTION AND PACKAGE TO STORE WHERE
PURCHASED. IF UNABLE TO RETURN TO STORE,
SEND REASON FOR DISSATISFACTION,
NAME, ADDRESS AND EMPTY PACKAGE TO:
DISCOUNT DRUG MART
211 COMMERCE DRIVE
MEDINA, OHIO 44256

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

*This product is not manufactured
or distributed by Wyeth LLC, owner
of the registered trademark Robitussin®
CoughGels®.

DISTRIBUTED BY:
DRUG MART - FOOD FAIR
211 COMMERCE DRIVE
MEDINA, OH 44256
www.discount-drugmart.com

Product of China
Packaged and Quality Assured in the USA
50844 ORG061966109

Drug Mart 44-661
Drug Mart 44-661

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53943-66153943-661-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
887c0b0f-4deb-448f-b6ac-f9679b742fba9f04638c-e828-4a58-8223-150b0b8ac1542021-05-11WarningsExact identifier
spl id: 887c0b0f-4deb-448f-b6ac-f9679b742fba
spl set id: 9f04638c-e828-4a58-8223-150b0b8ac154

Reported adverse events (FAERS/openFDA)#

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