Dometuss-da

Dometuss-da
SPL v4
SPL
SPL Set ID b5def3fb-90b9-4b7e-bb22-745804b0566a
Route
ORAL
Published
Effective Date 2024-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (1 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Red No. 33 Hydroxyethyl Cellulose (2000 Mpa.s At 1%) Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-01-21

Description

Chlorpheniramine Maleate 1 mg Phenylphrine HCL 2.5 mg

Purpose

Antihistamine Nasal Decongestant


Medication Information

Purpose

Antihistamine

Nasal Decongestant

Description

Chlorpheniramine Maleate 1 mg Phenylphrine HCL 2.5 mg

Uses
  • Temporarily relieves runny nose and sneezing
  • itching of the nose or throat and itchy
  • watery eyes due to hay fever or other respiratory allergies (allergic rhinitis)
  • temporarily relieves nasal congestion due to common cold
  • temporarily restores freer breathing through the nose
Warnings
  • Do not exceed recommended dosage.
  • A persistant cough may be a sign of a serious condition; if cough persists for more than one week, tend to recur, or is accompanied by fever, rash, or persistant headache, consult a doctor.
Directions

Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.

 

 
 Adults and children 12 years of age and over  Take 1 teaspoonful (5 mL) every 6 hours
 Children 6 to under 12 years of age  Take 1/2 teaspoonful (2.5 mL) every 6 hours
 Children under 6 years of age  Ask a doctor

 

Drug Facts

Chlorpheniramine Maleate 1 mg

Phenylphrine HCL 2.5 mg

Other Information

• store at room temperature 15°-30°C (59°-86°F).

Tamper Evident: Do not use if there is evidence of tampering.

Inactive Ingredients

Artificial grape flavor, citric acid, D&C red #33, FD&C blue #1, glycerin, methyl paraben (as preserative), propylene glycol, propyl paraben (as preseratie, purified water, sodium citrate, sucralose.

Questions Or Comments?

Please call (787) 767-3246

Do Not Use This Product
  • for persistant or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
  • If you are now taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; if you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
Dometuss Da Product Label

NDC 53809-206-04

DOMETUSS-DA

NASAL DECONGESTANT & ANTIHISTAMINIC

  • Itchy, Waterl Eyes
  • Runny Nose
  • Stuffy Nose
  • Sneezing

bubble gum flavor

4 fl. oz. (118 mL)

Rev: 05/13

Lot #

Exp:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

If Pregnant Or Breast Feeding

as a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • Temporarily relieves runny nose and sneezing
  • itching of the nose or throat and itchy
  • watery eyes due to hay fever or other respiratory allergies (allergic rhinitis)
  • temporarily relieves nasal congestion due to common cold
  • temporarily restores freer breathing through the nose
Purpose

Antihistamine

Nasal Decongestant

Warnings
  • Do not exceed recommended dosage.
  • A persistant cough may be a sign of a serious condition; if cough persists for more than one week, tend to recur, or is accompanied by fever, rash, or persistant headache, consult a doctor.
Directions

Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.

 

 
 Adults and children 12 years of age and over  Take 1 teaspoonful (5 mL) every 6 hours
 Children 6 to under 12 years of age  Take 1/2 teaspoonful (2.5 mL) every 6 hours
 Children under 6 years of age  Ask a doctor

 

Drug Facts

Chlorpheniramine Maleate 1 mg

Phenylphrine HCL 2.5 mg

Other Information

• store at room temperature 15°-30°C (59°-86°F).

Tamper Evident: Do not use if there is evidence of tampering.

Inactive Ingredients (Inactive ingredients)

Artificial grape flavor, citric acid, D&C red #33, FD&C blue #1, glycerin, methyl paraben (as preserative), propylene glycol, propyl paraben (as preseratie, purified water, sodium citrate, sucralose.

Questions Or Comments? (Questions or comments?)

Please call (787) 767-3246

Do Not Use This Product (Do not use this product)
  • for persistant or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
  • If you are now taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; if you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
Dometuss Da Product Label (DOMETUSS-DA product label)

NDC 53809-206-04

DOMETUSS-DA

NASAL DECONGESTANT & ANTIHISTAMINIC

  • Itchy, Waterl Eyes
  • Runny Nose
  • Stuffy Nose
  • Sneezing

bubble gum flavor

4 fl. oz. (118 mL)

Rev: 05/13

Lot #

Exp:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

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

as 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.


Advanced Ingredient Data


Raw Label Data

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