Desenfriol-ito Plus

SPL v1

SPL

SPL Set ID 4139bfdc-792f-698a-e063-6394a90ad1af

Route

ORAL

Published

Effective Date 2025-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg)

Inactive Ingredients

Sodium Citrate, Unspecified Form Sucralose Anhydrous Citric Acid Glycerin Menthol Propylene Glycol Water Sodium Benzoate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-15

Description

Dextromethorphan HBr USP 10 mg............. Cough suppressant Guaifenesin, USP 100 mg............................... Expectorant

Purpose

Dextromethorphan HBr USP 10 mg............. Cough suppressant Guaifenesin, USP 100 mg............................... Expectorant

Medication Information

Purpose

Dextromethorphan HBr USP 10 mg............. Cough suppressant Guaifenesin, USP 100 mg............................... Expectorant

Description

Dextromethorphan HBr USP 10 mg............. Cough suppressant Guaifenesin, USP 100 mg............................... Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Section 42229-5

Questions or comments?

Call 619-600-5632

Tamper evident: Do not use if inner seal under cap is broken or missing.

Exclusively distributed by

OPMX

Chula Vista, CA91910

Phone: 619-600-5632

Manufactured in

FDA Registered Facility

In the USA

Section 55105-1

Cough suppressant
Expectorant

Warnings

Warnings

Directions

take evey 4 hours
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product

Age	Dose
Adults and children 12 years and over	2 teaspoonful (10 mL)
Children 6 to under 12 years	1 teaspoonful (5 mL)
Children under 6 years	Ask a doctor

Do Not Use

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.

Other Information

Store at 20°-25°C (68° -77°F).
Do not refrigerate.
Retain carton for future reference on full labeling

Inactive Ingredients

anhydrous citric acid, cherry flavor, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

Stop Use and Ask A Doctor If

Stop use and ask a doctor ifcough lasts 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

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

Ask A Doctor Before Use If You Have

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

Principal Display Panel Desenfriolito

Active Ingredient (in Each 5 Ml) Purpose

Dextromethorphan HBr USP 10 mg............. Cough suppressant

Guaifenesin, USP 100 mg............................... Expectorant

Structured Label Content

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Section 42229-5 (42229-5)

Questions or comments?

Call 619-600-5632

Tamper evident: Do not use if inner seal under cap is broken or missing.

Exclusively distributed by

OPMX

Chula Vista, CA91910

Phone: 619-600-5632

Manufactured in

FDA Registered Facility

In the USA

Section 55105-1 (55105-1)

Cough suppressant
Expectorant

Warnings

Warnings

Directions

take evey 4 hours
do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
keep dosing cup with product

Age	Dose
Adults and children 12 years and over	2 teaspoonful (10 mL)
Children 6 to under 12 years	1 teaspoonful (5 mL)
Children under 6 years	Ask a doctor

Do Not Use (Do not use)

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.

Other Information (Other information)

Store at 20°-25°C (68° -77°F).
Do not refrigerate.
Retain carton for future reference on full labeling

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, cherry flavor, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor ifcough lasts 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)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Principal Display Panel Desenfriolito (PRINCIPAL DISPLAY PANEL DESENFRIOLITO)

Active Ingredient (in Each 5 Ml) Purpose (Active Ingredient (in each 5 mL) Purpose)

Dextromethorphan HBr USP 10 mg............. Cough suppressant

Guaifenesin, USP 100 mg............................... Expectorant

Advanced Ingredient Data

[{"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "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": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes", "42229-5": "Questions or comments? Call 619-600-5632 Tamper evident: Do not use if inner seal under cap is broken or missing. Exclusively distributed by OPMX Chula Vista, CA91910 Phone: 619-600-5632 Manufactured in FDA Registered Facility In the USA", "55105-1": "Cough suppressant Expectorant", "Warnings": "Warnings", "Directions": "take evey 4 hours do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product Age Dose Adults and children 12 years and over 2 teaspoonful (10 mL) Children 6 to under 12 years 1 teaspoonful (5 mL) Children under 6 years Ask a doctor", "Do not use": "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.", "Other information": "Store at 20°-25°C (68° -77°F). Do not refrigerate. Retain carton for future reference on full labeling", "Inactive ingredients": "anhydrous citric acid, cherry flavor, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.", "Stop use and ask a doctor if": "Stop use and ask a doctor if cough lasts 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": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema", "Active Ingredient (in each 5 mL) Purpose": "Dextromethorphan HBr USP 10 mg............. Cough suppressant Guaifenesin, USP 100 mg............................... Expectorant"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:43.815132 · Updated: 2026-03-14T23:13:05.198485