Dextromethorphan Hydrobromide Capsules, 15mg

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (15 mg)

Inactive Ingredients

Glycerin Gelatin, Unspecified Fd&c Red No. 40 Propyl Gallate Water Sorbitol Propylene Glycol Povidone K30 Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance

Shape: oval Color: red Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-11

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use

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

Dosage and Administration

Directions

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

age	dose
adults and children 12 years and over	take 2 capsules every 6 to 8 hours, as needed
children under 12 years	do not use

Description

Active ingredient (in each soft gelatin capsule) Dextromethorphan HBr, USP 15 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if 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.

Section 50569-3

Ask a doctor before use if you have

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

Section 50570-1

Do not use 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.

Section 51727-6

Inactive ingredients

FD & C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propyl gallate, propylene glycol, purified water, sorbital sorbitan solution

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Cough suppressant

Section 55106-9

Active ingredient (in each soft gelatin capsule)

Dextromethorphan HBr, USP 15 mg

Section 60561-8

Other information

store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)
protect from light

Manufactured By

Softgel Healthcare Pvt. Ltd.,

Survey No. 20/1, Vandalur-Kelambakkam Road,

Pudupakkam , chengalpattu district,

Tamilnadu - 603 103, India.

Mfg. Lic. No.:XXXXXXXXXXXX

Structured Label Content

Indications and Usage (34067-9)

Use

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

Dosage and Administration (34068-7)

Directions

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

age	dose
adults and children 12 years and over	take 2 capsules every 6 to 8 hours, as needed
children under 12 years	do not use

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if 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.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

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

Section 50570-1 (50570-1)

Do not use 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.

Section 51727-6 (51727-6)

Inactive ingredients

FD & C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propyl gallate, propylene glycol, purified water, sorbital sorbitan solution

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Section 55106-9 (55106-9)

Active ingredient (in each soft gelatin capsule)

Dextromethorphan HBr, USP 15 mg

Section 60561-8 (60561-8)

Other information

store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)
protect from light

Manufactured By

Softgel Healthcare Pvt. Ltd.,

Survey No. 20/1, Vandalur-Kelambakkam Road,

Pudupakkam , chengalpattu district,

Tamilnadu - 603 103, India.

Mfg. Lic. No.:XXXXXXXXXXXX

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYL GALLATE", "unii": "8D4SNN7V92", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.", "34068-7": "Directions 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 age dose adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed children under 12 years do not use", "34071-1": "Warnings", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if 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.", "50569-3": "Ask a doctor before use if you have a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema", "50570-1": "Do not use 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.", "51727-6": "Inactive ingredients FD & C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propyl gallate, propylene glycol, purified water, sorbital sorbitan solution", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Cough suppressant", "55106-9": "Active ingredient (in each soft gelatin capsule) Dextromethorphan HBr, USP 15 mg", "60561-8": "Other information store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light", "Manufactured By": "Softgel Healthcare Pvt. Ltd., Survey No. 20/1, Vandalur-Kelambakkam Road, Pudupakkam , chengalpattu district, Tamilnadu - 603 103, India. Mfg. Lic. No.:XXXXXXXXXXXX"}

Dextromethorphan Hydrobromide Capsules, 15mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information