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

Description

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

Purpose

Antihistamine Cough suppressant Nasal decongestant


Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

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

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

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

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.

Packaging

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.

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

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

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

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.

Packaging

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.

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

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