G-SUPRESS DX PEDIATRIC DROPS

Manufacturer
Kramer Novis
Effective date
2026-10-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-13 04:04:31

Label at a glance#

ProductG-SUPRESS DX PEDIATRIC DROPS
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves: • nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) • cough due to minor throat and bronchial irritation as may occur with the common cold

Dosage and administration

• do not use more than 6 doses in any 24-hour period • repeat every 4 hours • mL = milliliter • measure with the dosage device provided. Do not use with any other device • Children 2 to under 6 years of age: 1 mL • Children under 2 years of age: do not use.

Storage and handling

• Tamper Evident Feature: Do not use if security seal is torn, broken or missing • Store at controlled room temperature 15-30°C (59-86°F) • Avoid excessive heat and humidity.

Label contents#

Full prescribing information#

Active ingredients (in each 1 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, 5 mg
Guaifenesin, 50 mg
Phenylephrine HCl, 2.5 mg

Purposes

OTC - PURPOSE SECTION

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily relieves: • nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)
• cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

WARNINGS SECTION

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
• heart disease • thyroid disease • high blood pressure • diabetes • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with asthma.

When using this product, do not use more than directed.

Stop use and ask a doctor if
• your child gets nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not use more than 6 doses in any 24-hour period
• repeat every 4 hours
• mL = milliliter
• measure with the dosage device provided. Do not use with any other device
• Children 2 to under 6 years of age: 1 mL
• Children under 2 years of age: do not use.

Other information

STORAGE AND HANDLING SECTION

• Tamper Evident Feature: Do not use if security seal is torn, broken or missing
• Store at controlled room temperature 15-30°C (59-86°F)
• Avoid excessive heat and humidity.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-787-767-2072 You may also report serious side effects to this phone number.
Call weekdays from 8AM to 4PM AST.

SPL UNCLASSIFIED SECTION

PEDIATRIC DROPS

2 to 6 years

Compare to Supress® DX

By the makers of Supress® DX

COUGH SUPPRESSANT
Dextromethorphan HBr

EXPECTORANT
Guaifenesin

NASAL DECONGESTANT
Phenylephrine HCl

DYE FREE

Cherry Flavor

Sugar & Alcohol FREE

NET CONTENTS: 30ML (1 Fl. Oz.)

KramerNovis
Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis,
San Juan, PR 00917
www.kramernovis.com

Rev. 06/26 Rev. 2

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

G-SUPPRESS DXG-SUPPRESS DX

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130352083651014GTIN-13: 0352083651014
EAN-13: 0352083651014
GTIN-12: 352083651014
UPC-A: 352083651014
GTIN storage (14 digits): 00352083651014
52083651-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52083-65152083-651-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCINEX INSTASOOTHE COUGHDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC0d99237c-0b52-0af6-e063-6394a90aba142026-08-03WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Mucinex Childrens Mighty Chews CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC155e07b3-0a08-3be8-e063-6394a90a76352026-05-31WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Delsym CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCa43d59f9-3a6c-4a7c-b98d-b86d6035f7162026-05-27WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Cough Suppressant AdultDEXTROMETHORPHAN HYDROBROMIDERugby Laboratories47b713bd-4c1e-f44a-e063-6294a90a63d32026-05-25WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Nuvicare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDENUVICARE LLCec1d3dd6-2a8b-4487-81a2-be6313e976102026-03-24WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Gencare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEPIONEER LIFE SCIENCES, LLC7a02cbb6-c083-4d91-977b-9d53cb3e27842026-03-24WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Creomulsion For ChildrenDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d0e96c-1cc3-4961-e054-00144ff88e882026-02-17WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Creomulsion Cough Medicine Adult FormulaDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d07486-99b7-5c06-e054-00144ff8d46c2026-02-17WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Mixed Berry Sore Throat and Cough lozengeDEXTROMETHORPHAN HYDROBROMIDEMeijer Distribution, Inc.304ff4db-201a-60a4-e054-00144ff8d46c2026-02-02WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Goodmeds Non-Drowsy Cough ReliefDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.32482083-3f51-41f4-8d20-bedf143e066d2025-12-29WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
ROBITUSSIN LONG-ACTING COUGH Soft CHEWSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLCf22248b7-7abd-4df7-a986-dae357ebe8f12025-11-25WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
BupropiDexDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.90cc9bcd-7891-4324-a1f4-f6df7a0457e02025-10-06WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
DextabsDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.71b567df-844a-4563-b85a-f4592233f37d2025-10-06WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
ValuMeds Cough Relief, Dextromethorphan HbrDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.b16a81db-d9bc-4cce-8ec2-dc189184931e2025-09-03WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Right Remedies Adult Long Lasting Cough Relief SoftgelDEXTROMETHORPHAN HYDROBROMIDEStrive Pharmaceuticals Inc.e3ea468e-4e12-4dae-b222-8e32456b77b82025-01-02WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Cough ReliefDEXTROMETHORPHAN HYDROBROMIDEAdvanced Rx LLC297e10e3-e740-4434-91a2-2e5c54985d332025-01-01WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
Long Acting Cough SoftgelsDEXTROMETHORPHAN HYDROBROMIDECVS PHARMACY, INC322daee6-c61d-43d3-a54d-a354fd3df2422025-01-01WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE
QUALITY CHOICE Long Acting Cough SoftgelDEXTROMETHORPHAN HYDROBROMIDEChain Drug Marketing Association, Inc.f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c2024-08-16WarningsName fallback
generic name: DEXTROMETHORPHAN HYDROBROMIDE

Reported adverse events (FAERS/openFDA)#

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