Giltuss HBP Cough and Chest Congestion

Manufacturer
Dextrum Laboratories Inc.
Effective date
2025-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:05

Label at a glance#

ProductGiltuss HBP Cough and Chest Congestion
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure13 sections

Indications and uses

Purposes Cough supresant Expectorant Uses Temporary relieves, cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants , the intensity of coughing, the impulse to cough to help you get to sleep, help loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes

Dosage and administration

Directions Do not exceed recommended dosage Do not take more than 6 doses in any 24 hours period Keep dosing cup with product ml= mililiters Adults and children 12 years & over 10 ml every 4 hours children 6 to under 12 years of age 5 ml every 4 hours children 4 to under 6 years of age 2.5 ml every 4 hours children under 4 years of age Consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Dextromethorphan HBr, 20 mg

Guaifenesin, 200 mg Active ingredientsActive ingredients

Purposes and Uses

OTC - PURPOSE SECTION

Purposes

Cough supresant

Expectorant

Uses

Temporary relieves, cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants , the intensity of coughing, the impulse to cough to help you get to sleep, help loosen phlegm ( mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes usesuses

Warnings

WARNINGS SECTION

Warnings

Do not use

If you are taking a prescription monoamine oxidase inhibitor (MAOI) ( certains drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you dont know is your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

WarningsWarnings

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have, a cough with too much phlegm( mucus) , a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema, when using this product do not use more than directed. Ask a doctorAsk a doctor

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

cough lasts for more than 7 days , come back, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition. Stop useStop use

If pregnant

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast- feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately If pregnancyIf pregnancy

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Do not exceed recommended dosage

Do not take more than 6 doses in any 24 hours period

Keep dosing cup with product

ml= mililiters

Adults and children 12 years & over 10 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

children 4 to under 6 years of age 2.5 ml every 4 hours

children under 4 years of age Consult a doctor DirectionsDirections

Other information

OTHER SAFETY INFORMATION

Other information

Tamper evident : Do not use if safety seal is broken or missing

Store at controlled Other informationOther informationroom temperature 15-30 °C (59° -86 ° F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, flavor, methylparaben, propylene glycol, propylparaben, purified water and sucralose Inactive ingredientsInactive ingredients

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-787-848-9114, Monday-Friday 9AM – 5PM EST

Call your doctor for medical advice in the event of side effects. QuestionsQuestions

keep out of seach children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keepkeep

keep out of reach of the children.

In case of accidental overdose get medical professional helph or contact a Poison Control Center immediately

INDICATIONS & USAGE SECTION

Indication and usage

Do not exceed recommended dosage

Do not take more than 6 doses in any 24 hours period

Keep dosing cup with product

ml= mililiters

Adults and children 12 years & over 10 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

children 4 to under 6 years of age 2.5 ml every 4 hours

children under 4 years of age Consult a doctor

Indication and userIndication and user

Principal panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal panelPrincipal panelMaximum strength

High Blood Pressure

Giltuss HBP

Cough & Chest Congestion

Alcohol free, Sugar Free, Dye free, Non -Drowsy

Cough and cold, chest congestion, liquifies and loosens phlegm and mucus

Raspberry flavor

4 floz 118 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65852-006-04Giltuss HBP Cough and Chest Congestion118 mL in 1 BOTTLE, PLASTICSOLUTION1181
65852-006-04Giltuss HBP Cough and Chest Congestion1 in 1 CARTONSOLUTION11

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65852-00665852-006-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
ndc (package): 65852-006-04
ndc (product): 65852-006
ndc11 (package): 65852000604
spl id: 3f68e68a-cf33-9df8-e063-6394a90a3012
spl set id: 3f68e68a-cf32-9df8-e063-6394a90a3012

Reported adverse events (FAERS/openFDA)#

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