DOMETUSS-G

Manufacturer
Domel Laboratories
Effective date
2016-01-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:29:21

Label at a glance#

ProductDOMETUSS-G
Active ingredientACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

minor aches and pains associated with headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more produtive temporarily reduces cough due to minor throst and bronchial irritation associated with a cold calm the cough control center, and relieves coughing Temporarily relief nasal congestion due to the common cold hay fever or other respi...

Dosage and administration

   Age  Dose  adults and children 12 years of age and over  2 tablets enery 4 hours.  children 6 to 12 years of age  1 tablet every 4 hours.  children under 12 years of age  Consult a doctor  

Label contents#

Full prescribing information#

Drug FactsActive ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Guaifenesin 100 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCL 5 mg

Purpose

OTC - PURPOSE SECTION

Analgesic, Fever reducer

Expectorant

Cough Suppressant

Nasal Decongestant

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

  • minor aches and pains associated with headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more produtive
  • temporarily reduces cough due to minor throst and bronchial irritation associated with a cold
  • calm the cough control center, and relieves coughing
  • Temporarily relief nasal congestion due to the common cold
  • hay fever or other respiratory allergies
  • sinus congestion and pressure

Warniings

WARNINGS SECTION

  • Do not exceed the recommended dosage
  • If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.
  • Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers
  • Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if you or your child take more than 4 does in 24 hours, wich is the maxium daily allowance.
  • A persistant cough may be a sign of a serious condition. If cough persists for more than 1 week , tends to recur, or accompanied by fever, rash or persistant headache, consult a doctor.
  • Do not give to children under 3 years of age or use for more than10 days unless directed by a physicisn.
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

Do not use

OTC - DO NOT USE SECTION

  • if you are now taken a prescription Monoaminoxidase 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
  • with any other drug containing acetaminophen (prescription or non-prescription)
  • with any other drug containing acetaminophen, ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any of the inactive ingredients in the product
  • for more than 10 days for pain, unless directed by a doctor.
  • for more than 3 days for a fever, unless directed by a doctor

Do not take this productDo not give this product if you have

OTC - DO NOT USE SECTION

for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is acompanied by excessive phlegm (mucus), unless directed by a doctor.

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes or difficulty in urination due to the prostate gland unless directed by a doctor.

Ask a doctor before use if you have:

  • liver disease
  • if you are taking the blood thinning drug warfarin.

Stop using this product and ask a doctor if:

OTC - STOP USE SECTION

  • if new symptoms occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • pain or fever persists or get worse. Thease could be signs of a serious condition

Overdose Warning:

OVERDOSAGE SECTION

Taking more than the recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

If you are pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions: Do not take more than 4 doses in any 24 hours period.

DOSAGE & ADMINISTRATION SECTION

 
 Age Dose
 adults and children 12 years of age and over 2 tablets enery 4 hours.
 children 6 to 12 years of age 1 tablet every 4 hours.
 children under 12 years of age Consult a doctor

 

Other information

OTHER SAFETY 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 INGREDIENT SECTION

Dicalcium phosphate, magnesium stearate, maltodextrin, mirocrystalline cellulose, povidone, silicon dioxide, sodium carboxymethyl starch, starch, stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

Please call (787) 767 3246

Domel Dometuss-G product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53809-205-04

DOMETUSS-G

ACETAMINOPHEN/GUAIFENESIN

DEXTROMETHORPHAN HBR

PHENYLEPHRINE HCL

  • Analgesic, Fever Reducer
  • Expectorant
  • Cough Suppressant
  • Nasal Decongestant

Rev: 09/13

Lot #:

Exp:

Manufactured for:

DOMEL

San Juan, Puero Rico, 00924

Domel Dometuss 205Domel Dometuss 205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53809-205-042020-12-18C16284748780-19d75b9d0-277f-f424-e053-dadaa90a57ceDOMETUSS-G
53809-205-042020-01-31C16284748780-19d75b9d0-277f-f424-e053-dadaa90a57ceDOMETUSS-G

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53809-20553809-205-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
884cb63d-33fa-4c20-a808-60b081f5394d7e947e5e-3646-44f7-8e6b-ac539fcbf7bf2019-11-20WarningsExact identifier
spl set id: 7e947e5e-3646-44f7-8e6b-ac539fcbf7bf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.