histex™-dm syrup new formulation

Drug Facts

Composition & Product

Active Ingredients

dextromethorphan (20 mg) pseudoephedrine (30 mg) triprolidine (2.5 mg)

Inactive Ingredients

citric acid monohydrate glycerin propylene glycol water sodium citrate, unspecified form saccharin sodium sorbitol sodium benzoate grape

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-03-10

Medication Information

Warnings

Do not exceed recommended dosage.

Uses

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

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

Directions

Do not exceed recommended dosage.

AGE	DOSE
Adults and Children 12 years of age and older:	1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age	½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor.
Children under 6 years of age	Consult a doctor

Other Information

Store at 15°-30° C (59°-86° F).

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

Inactive Ingredients

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Bensoate, Soduim Citrate, Sodium Saccharin, Sorbitol Solution.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children.

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

Section 53414-9

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

Section 55105-1

Active ingredients (in each 5 mL teaspoonful)	Purpose
Dextromethorphan HBr 20 mg	Cough Suppressant
Pseudoephedrine HCI 30 mg	Nasal Decongestant
Triprolidine HCl 2.5 mg	Antihistamine

Questions? Comments?

Call 1-866-633-9033.

Manufactured for: Allegis Pharmaceuticals, Inc.

Canton MS 39046

www.allegispharma.com

Rev. 01/2025

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 giving this product.

When Using This Product

excitability may occur, especially in children
may cause drowsiness
alcohol, sedatives and tranquilizers may increase the drowsiness effect
avoid alcoholic beverages
use caution 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.
new symptoms occur

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have

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

Ask a doctor before use if you are taking sedatives or tranquilizers

Principal Display Panel 473 Ml Bottle Label

NDC 28595-310-16

Antihistamine - Nasal Decongestant - Cough Suppressant

HISTEX™-DM New Formulation

Syrup

Each teaspoonful (5 mL)

contains:

Dextromethorphan HBr 20 mg

Pseudoephedrine HCI 30mg

Triprolidine HCl 2.5 mg

Sugar-Free - Dye Free - Alcohol Free

Grape Flavor

16 fl oz (473 mL)

Structured Label Content

Warnings

Do not exceed recommended dosage.

Uses

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

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

Directions

Do not exceed recommended dosage.

AGE	DOSE
Adults and Children 12 years of age and older:	1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age	½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor.
Children under 6 years of age	Consult a doctor

Other Information

Store at 15°-30° C (59°-86° F).

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

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Bensoate, Soduim Citrate, Sodium Saccharin, Sorbitol Solution.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children.

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients (in each 5 mL teaspoonful)	Purpose
Dextromethorphan HBr 20 mg	Cough Suppressant
Pseudoephedrine HCI 30 mg	Nasal Decongestant
Triprolidine HCl 2.5 mg	Antihistamine

Questions? Comments?

Call 1-866-633-9033.

Manufactured for: Allegis Pharmaceuticals, Inc.

Canton MS 39046

www.allegispharma.com

Rev. 01/2025

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 giving this product.

When Using This Product (When using this product)

excitability may occur, especially in children
may cause drowsiness
alcohol, sedatives and tranquilizers may increase the drowsiness effect
avoid alcoholic beverages
use caution 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.
new symptoms occur

These could be signs of a serious condition.

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
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema
a cough that occurs with too much phlegm (mucus)
trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

NDC 28595-310-16

Antihistamine - Nasal Decongestant - Cough Suppressant

HISTEX™-DM New Formulation

Syrup

Each teaspoonful (5 mL)

contains:

Dextromethorphan HBr 20 mg

Pseudoephedrine HCI 30mg

Triprolidine HCl 2.5 mg

Sugar-Free - Dye Free - Alcohol Free

Grape Flavor

16 fl oz (473 mL)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat or bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages", "42229-5": "Drug Facts", "50565-1": "Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each 5 mL teaspoonful) Purpose Dextromethorphan HBr 20 mg Cough Suppressant Pseudoephedrine HCI 30 mg Nasal Decongestant Triprolidine HCl 2.5 mg Antihistamine", "Warnings": "Do not exceed recommended dosage.", "Directions": "Do not exceed recommended dosage. AGE DOSE Adults and Children 12 years of age and older: 1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor Children 6 to under 12 years of age ½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor. Children under 6 years of age Consult a doctor", "Other Information": "Store at 15°-30° C (59°-86° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.", "Inactive ingredients": "Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Bensoate, Soduim Citrate, Sodium Saccharin, Sorbitol Solution.", "Questions? Comments?": "Call 1-866-633-9033. Manufactured for: Allegis Pharmaceuticals, Inc. Canton MS 39046 www.allegispharma.com Rev. 01/2025", "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 giving this product.", "When using this product": "excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution 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. new symptoms occur These could be signs of a serious condition.", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis heart disease high blood pressure thyroid disease diabetes glaucoma a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema a cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers", "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label": "NDC 28595-310-16 Antihistamine - Nasal Decongestant - Cough Suppressant HISTEX™-DM New Formulation Syrup Each teaspoonful (5 mL) contains: Dextromethorphan HBr 20 mg Pseudoephedrine HCI 30mg Triprolidine HCl 2.5 mg Sugar-Free - Dye Free - Alcohol Free Grape Flavor 16 fl oz (473 mL)"}

histex™-dm syrup new formulation

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information