Ed-rynexdm 0204

SPL v14

SPL

SPL Set ID 7be2c282-24ba-4f19-9b14-872d3f5746a7

Route

ORAL

Published

Effective Date 2025-12-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (2.5 mg) Brompheniramine (1 mg) Dextromethorphan (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Citrate, Unspecified Form Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-03-14

Description

Active ingredients (in each 5 mL teaspoonful) Brompheniramine Maleate 1mg Dextromethorphan Hydrobromide 5 mg Phenylephrine Hydrochloride 2.5 mg

Purpose

Antihistamine Antitussive Nasal Decongestant

Medication Information

Purpose

Antihistamine

Antitussive

Nasal Decongestant

Description

Active ingredients (in each 5 mL teaspoonful) Brompheniramine Maleate 1mg Dextromethorphan Hydrobromide 5 mg Phenylephrine Hydrochloride 2.5 mg

Uses

temporarily relieves these symptoms due to the common cold, hay fever, (allergic rhinitis) or other upper respiratory allergies:

runny nose
sneezing
itching of nose or throat
itchy, watery eyes
cough due to minor throat and bronchial irritation
nasal congestion
reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and older:	4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age:	2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours.
Children under 6 years of age:	Consult a doctor

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Brompheniramine Maleate 1mg

Dextromethorphan Hydrobromide 5 mg

Phenylephrine Hydrochloride 2.5 mg

Other Information

Store at 59° - 86°F (15° - 30°C)

Product Packaging

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 00485-0204-16

Rynex DM Liquid

ANTIHISTAMINE ∙ ANTITUSSIVE

NASAL DECONGESTANT

Each 5 mL (one teaspoonful) for oral administration contains:

Brompheniramine Maleate, USP..................1 mg

Dextromethorphan HBr, USP.......................5 mg

Phenylephrine HCl, USP...........................2.5 mg

ALCOHOL FREE ∙ DYE FREE

GLUTEN FREE ∙ SUGAR FREE

______________________________________________

FOR PROFESSIONAL USE ONLY

Tutti-Frutti Flavor

Manufactured for:

EDWARDS

Pharmaceuticals, Inc.

Ripley, MS 38663

16 fl oz (473 mL)

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant cap.

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

The labeling for this product includes professional labeling which is not

intended for use by the general public.

Manufactured for: Edwards Pharmaceuticals, Inc., Ripley, MS 38663

Iss. 01/12

Inactive Ingredients

Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

Questions? Comments?

Call 1-800-664-1490

Do Not Use This Product

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.

When Using This Product

excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of the 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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating to to an enlarged prostate gland
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)
heart disease
high blood pressure
thyroid disease
diabetes

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

temporarily relieves these symptoms due to the common cold, hay fever, (allergic rhinitis) or other upper respiratory allergies:

runny nose
sneezing
itching of nose or throat
itchy, watery eyes
cough due to minor throat and bronchial irritation
nasal congestion
reduces swelling of nasal passages

Purpose

Antihistamine

Antitussive

Nasal Decongestant

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and older:	4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours.
Children 6 to under 12 years of age:	2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours.
Children under 6 years of age:	Consult a doctor

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Brompheniramine Maleate 1mg

Dextromethorphan Hydrobromide 5 mg

Phenylephrine Hydrochloride 2.5 mg

Other Information (Other information)

Store at 59° - 86°F (15° - 30°C)

Product Packaging (PRODUCT PACKAGING)

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

Questions? Comments?

Call 1-800-664-1490

Do Not Use This Product (Do not use this product)

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.

When Using This Product (When using this product)

excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery

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

nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur

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

ask a health professional before use.

Keep Out of the Reach of Children. (Keep out of the 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)

a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating to to an enlarged prostate gland
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)
heart disease
high blood pressure
thyroid disease
diabetes

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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 CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "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": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BROMPHENIRAMINE", "unii": "H57G17P2FN", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to the common cold, hay fever, (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages", "Purpose": "Antihistamine Antitussive Nasal Decongestant", "Warnings": "Do not exceed recommended dosage.", "Directions": "Do not exceed recommended dosage. Adults and children 12 years of age and older: 4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours. Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours. Children under 6 years of age: Consult a doctor", "Drug Facts": "Active ingredients (in each 5 mL teaspoonful) Brompheniramine Maleate 1mg Dextromethorphan Hydrobromide 5 mg Phenylephrine Hydrochloride 2.5 mg", "Other information": "Store at 59° - 86°F (15° - 30°C)", "PRODUCT PACKAGING": "The packaging below represents the labeling currently used: Principal display panel and side panel for 473 mL label: NDC 00485-0204-16 Rynex DM Liquid ANTIHISTAMINE ∙ ANTITUSSIVE NASAL DECONGESTANT Each 5 mL (one teaspoonful) for oral administration contains: Brompheniramine Maleate, USP..................1 mg Dextromethorphan HBr, USP.......................5 mg Phenylephrine HCl, USP...........................2.5 mg ALCOHOL FREE ∙ DYE FREE GLUTEN FREE ∙ SUGAR FREE ______________________________________________ FOR PROFESSIONAL USE ONLY Tutti-Frutti Flavor Manufactured for: EDWARDS Pharmaceuticals, Inc. Ripley, MS 38663 16 fl oz (473 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Dispense in a tight, light-resistant container with a child-resistant cap. THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER. The labeling for this product includes professional labeling which is not intended for use by the general public. Manufactured for: Edwards Pharmaceuticals, Inc., Ripley, MS 38663 Iss. 01/12", "Inactive ingredients": "Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.", "Questions? Comments?": "Call 1-800-664-1490", "Do not use this product": "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.", "When using this product": "excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of the 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": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating to to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.886903 · Updated: 2026-03-14T23:12:02.945870