supress a

supress a
SPL v3
SPL
SPL Set ID f0bec5f5-4d76-471e-9024-557eba848b93
Route
oral
Published
Effective Date 2025-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dexbrompheniramine (1 mg) dextromethorphan (10 mg) phenylephrine (5 mg)
Inactive Ingredients
citric acid monohydrate glycerin methylparaben polysorbate 20 propylene glycol propylparaben water sodium citrate sucralose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-08-01

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

Dexbrompheniramine Maleate, 1 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl, 5 mg


Medication Information

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage 

• excitability may occur, especially in children • may cause marked drowsiness • sedatives and tranquilizers may increase drowsiness effect

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • new symptoms occur • symptoms do not improve within 7 days or are accompanied by fever • 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.

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy nose or throat • runny nose • itchy, watery eyes

• nasal congestion

• temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants

• temporarily restores freer breathing through nose

Purpose

Antihistamine Cough suppressant Nasal decongestant

Directions

• do not use more than 6 doses in any 24-hour period.

• repeat every 4 hours.

• measure with the dosage device provided. Do not use with any other device

• children 6 to under 12 years of age: 1 mL • children under 6 years of age, consult a docotor.

Other Information
  • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.
  • Store at controlled room temperature 15°-30°C (59° to 86°F).
  • Avoid excessive heat and humidity.
Inactive Ingredients

Citric acid, flavor, glycerin, methylparaben, polysorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Description

Dexbrompheniramine Maleate, 1 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl, 5 mg

Section 42229-5

For relief of:

+ Itchy nose or throat

+ Coughs

+ Stuffy nose

+ Sinus congestion

Sugar, Dye & Alcohol Free

PSEUDOEPHEDRINE & PPA FREE

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

​Manufactured in the USA for Kramer Novis, San Juan, PR 00917. www.kramernovis.com

Section 50565-1

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

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Packaging

Questions Or Comments?

call weekdays from 8 am to 4 pm AST at 1.787.767.2072

Active Ingredients (in Each 1 Ml)

Dexbrompheniramine Maleate, 1 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCl, 5 mg


Structured Label Content

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage 

• excitability may occur, especially in children • may cause marked drowsiness • sedatives and tranquilizers may increase drowsiness effect

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • new symptoms occur • symptoms do not improve within 7 days or are accompanied by fever • 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.

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy nose or throat • runny nose • itchy, watery eyes

• nasal congestion

• temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants

• temporarily restores freer breathing through nose

Directions

• do not use more than 6 doses in any 24-hour period.

• repeat every 4 hours.

• measure with the dosage device provided. Do not use with any other device

• children 6 to under 12 years of age: 1 mL • children under 6 years of age, consult a docotor.

Other Information (Other information)
  • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.
  • Store at controlled room temperature 15°-30°C (59° to 86°F).
  • Avoid excessive heat and humidity.
Inactive Ingredients (Inactive ingredients)

Citric acid, flavor, glycerin, methylparaben, polysorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Section 42229-5 (42229-5)

For relief of:

+ Itchy nose or throat

+ Coughs

+ Stuffy nose

+ Sinus congestion

Sugar, Dye & Alcohol Free

PSEUDOEPHEDRINE & PPA FREE

RETAIN CARTON FOR FULL PRESCRIBING INFORMATION

​Manufactured in the USA for Kramer Novis, San Juan, PR 00917. www.kramernovis.com

Section 50565-1 (50565-1)

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

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Packaging

Questions Or Comments? (Questions or comments?)

call weekdays from 8 am to 4 pm AST at 1.787.767.2072

Active Ingredients (in Each 1 Ml) (Active ingredients (in each 1 mL))

Dexbrompheniramine Maleate, 1 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCl, 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)