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Giltuss HBP Cough and Chest Congestion — v1

Giltuss HBP Cough and Chest Congestion

8 Views

Version

Effective date

September 22, 2025

Original packager

Yes

Sections captured

Identifiers

Document ID: 3f68e68a-cf33-9df8-e063-6394a90a3012
Set ID: 3f68e68a-cf32-9df8-e063-6394a90a3012
Application numbers: M012
Product NDCs: 65852-006
Package NDCs: 65852-006-04
Original packager NDCs: —

Names & Manufacturers

Brand names: Giltuss HBP Cough and Chest Congestion
Generic names: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Manufacturer names: Dextrum Laboratories Inc.
Product types: HUMAN OTC DRUG

Substances & Pharmacology

Substance names: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Routes: ORAL
Pharmacologic class (PE): Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions [PE]
Pharmacologic class (EPC): Expectorant [EPC]
Pharmacologic class (CS): —
Mechanism of action: —

Other identifiers

NUI: N0000008867, N0000009560, N0000193956
RxCUI: —
UNII: 495W7451VQ, 9D2RTI9KYH
UPC: —

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients Active Ingredients Dextromethorphan HBr, 20 mg Guaifenesin, 200 mg Active ingredients

Ask Doctor (1)

Sequence 1

Ask a doctor 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 doctor

Dosage And Administration (1)

Sequence 1

Directions 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 Directions

Inactive Ingredient (1)

Sequence 1

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

Indications And Usage (1)

Sequence 1

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 user

Keep Out Of Reach Of Children (1)

Sequence 1

keep out of seach children keep out of reach of the children. In case of accidental overdose get medical professional helph or contact a Poison Control Center immediately keep

Other Safety Information (1)

Sequence 1

Other information Other information Tamper evident : Do not use if safety seal is broken or missing Store at controlled room temperature 15-30 °C (59° -86 ° F) Other information

Package Label Principal Display Panel (1)

Sequence 1

Principal panel Maximum 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 Principal panel

Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant 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 pregnancy

Purpose (1)

Sequence 1

Purposes 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 uses

Questions (1)

Sequence 1

Questions or comments 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. Questions

Spl Product Data Elements (1)

Sequence 1

Giltuss HBP Cough and Chest Congestion Dextromethorphan hydrobromide, Guaifenesin CITRIC ACID RASPBERRY PROPYLPARABEN METHYLPARABEN WATER SUCRALOSE GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PROPYLENE GLYCOL

Stop Use (1)

Sequence 1

Stop use and ask a doctor 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 use

Warnings (1)

Sequence 1

Warnings 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. Warnings

OpenFDA raw payload

{'application_number': ['M012'],
 'brand_name': ['Giltuss HBP Cough and Chest Congestion'],
 'generic_name': ['DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN'],
 'is_original_packager': [True],
 'manufacturer_name': ['Dextrum Laboratories Inc.'],
 'nui': ['N0000193956', 'N0000008867', 'N0000009560'],
 'package_ndc': ['65852-006-04'],
 'pharm_class_epc': ['Expectorant [EPC]'],
 'pharm_class_pe': ['Decreased Respiratory Secretion Viscosity [PE]',
                    'Increased Respiratory Secretions [PE]'],
 'product_ndc': ['65852-006'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['3f68e68a-cf33-9df8-e063-6394a90a3012'],
 'spl_set_id': ['3f68e68a-cf32-9df8-e063-6394a90a3012'],
 'substance_name': ['DEXTROMETHORPHAN HYDROBROMIDE', 'GUAIFENESIN'],
 'unii': ['9D2RTI9KYH', '495W7451VQ']}