Cough Relief

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (15 mg)

Inactive Ingredients

Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol 400 Propylene Glycol Povidone K30 Water

Identifiers & Packaging

Pill Appearance

Imprint: 904 Shape: oval Color: red Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-01

Medication Information

Purpose

Cough suppressant

Description

Dextromethorphan HBr, USP 15 mg

Uses

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

Section 51945-4

NDC 80513-311-06

Cough Relief

Warnings

Do not useif 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.

Directions

do not take more than 8 softgels 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 older	take 2 softgels every 6 to 8 hours, as needed
children under 12 years	do not use

Drug Facts

Questions?

Call 1-800-630-8895

Distributed By:

Advanced Rx LLC

1942 NE 163rd St

North Miami Beach,

FL 33162 U.S.A.

Other Information

• store between 20° and 25°C (68°–77°F)

• avoid excessive heat above 40°C (104°F)

• protect from light

• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

Edible Ink, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol 400, POLYSORB, Propylene Glycol, Purified Water, Povidone K30.

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.

If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

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

Active Ingredient (in Each Tablet)

Dextromethorphan HBr, USP 15 mg

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

Structured Label Content

Uses

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

Section 51945-4 (51945-4)

NDC 80513-311-06

Cough Relief

Purpose

Cough suppressant

Warnings

Do not useif 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.

Directions

do not take more than 8 softgels 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 older	take 2 softgels every 6 to 8 hours, as needed
children under 12 years	do not use

Drug Facts

Questions?

Call 1-800-630-8895

Distributed By: (Distributed by: )

Advanced Rx LLC

1942 NE 163rd St

North Miami Beach,

FL 33162 U.S.A.

Other Information (Other information)

• store between 20° and 25°C (68°–77°F)

• avoid excessive heat above 40°C (104°F)

• protect from light

• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients (Inactive ingredients)

Edible Ink, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol 400, POLYSORB, Propylene Glycol, Purified Water, Povidone K30.

Stop Use and Ask A Doctor If (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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Dextromethorphan HBr, USP 15 mg

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data

[{"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.", "51945-4": "NDC 80513-311-06 Cough Relief", "Purpose": "Cough suppressant", "Warnings": "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.", "Directions": "do not take more than 8 softgels 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 older take 2 softgels every 6 to 8 hours, as needed children under 12 years do not use", "Questions?": "Call 1-800-630-8895", "Distributed by: ": "Advanced Rx LLC 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A.", "Other information": "• store between 20° and 25°C (68°–77°F) • avoid excessive heat above 40°C (104°F) • protect from light • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED", "Inactive ingredients": "Edible Ink, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol 400, POLYSORB, Propylene Glycol, Purified Water, Povidone K30.", "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.", "If pregnant or breast-feeding,": "ask a health professional before use", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Active Ingredient (in each tablet)": "Dextromethorphan HBr, USP 15 mg", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information