Dextromethorphan Hbr Usp 15 Mg Liquid Gels

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (15 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Glycerin Isopropyl Alcohol Medium-chain Triglycerides Polyethylene Glycol, Unspecified Povidone, Unspecified Propyl Gallate Propylene Glycol Water Sorbitol Sorbitan

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-09-04

Medication Information

Purpose

Cough Suppressant

Description

Dextromethorphan HBr, USP 15 mg

Use

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

Section 42229-5

Rugby ^®

Compare to the active ingredient in Robitussin^® CoughGels^®*

ADULT

Relieves:

Cough for up to 8 hours

Non-Drowsy

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin^® CoughGels^®.

Distributed by:

RUGBY^® LABORATORIES

Livonia, MI 48152

www.rugbylaboratories.com

Product of UAE

Packaged and Quality

Assured in the USA

Section 50565-1

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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.

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

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 can be signs of a serious condition.

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

Packaging

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

Other Information

• store at 20°-25°C(68°-77°F)

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

• protect from light

Inactive Ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene gycol, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-800-645-2158

Active Ingredient (in Each Softgel)

Dextromethorphan HBr, USP 15 mg

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Rugby ^®

Compare to the active ingredient in Robitussin^® CoughGels^®*

ADULT

Relieves:

Cough for up to 8 hours

Non-Drowsy

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin^® CoughGels^®.

Distributed by:

RUGBY^® LABORATORIES

Livonia, MI 48152

www.rugbylaboratories.com

Product of UAE

Packaged and Quality

Assured in the USA

Section 50565-1 (50565-1)

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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.

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

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 can be signs of a serious condition.

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

Packaging

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

Other Information (Other information)

• store at 20°-25°C(68°-77°F)

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

• protect from light

Inactive Ingredients (Inactive ingredients)

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene gycol, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

1-800-645-2158

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Dextromethorphan HBr, USP 15 mg

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYL GALLATE", "unii": "8D4SNN7V92", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.", "42229-5": "Rugby ® Compare to the active ingredient in Robitussin ® CoughGels ® * ADULT Relieves: Cough for up to 8 hours Non-Drowsy TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE *This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin ® CoughGels ® . Distributed by: RUGBY ® LABORATORIES Livonia, MI 48152 www.rugbylaboratories.com Product of UAE Packaged and Quality Assured in the USA", "50565-1": "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.", "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. 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 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 can be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use.", "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", "Other information": "• store at 20°-25°C(68°-77°F) • avoid excessive heat above 40°C(104°F) • protect from light", "Inactive ingredients": "edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene gycol, purified water, sorbitol sorbitan solution", "Questions or comments?": "1-800-645-2158", "Active ingredient (in each softgel)": "Dextromethorphan HBr, USP 15 mg"}

Dextromethorphan Hbr Usp 15 Mg Liquid Gels

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information