Dometuss

Dometuss
SPL v1
SPL
SPL Set ID 3fcace53-a81f-e774-e063-6294a90a32fa
Route
ORAL
Published
Effective Date 2016-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (2 mg) Phenylephrine (5 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Methylparaben Citric Acid Monohydrate Propylparaben Sucralose Water Sodium Citrate Monohydrate Propylene Glycol

Identifiers & Packaging

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

Description

Anthistamine cough suppresant nasal descongestant. Use For temporary relief of runny nose, sneezing, itching of the nose orthroat and itchywatery eyes due to hay fever. Temporary relieves cough due to minor throat and bronchial irritation as may occur with the common cold. temporary restores freer breathing through the nose.


Medication Information

Warnings and Precautions

Warnings: Do not use

  • To sedate a child or to make a child sleepy.
  • If you are now taking a prescription monoamine oxidose inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditiosn 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, asl a doctor or pharmacist before taking this product.
Description

Anthistamine cough suppresant nasal descongestant. Use For temporary relief of runny nose, sneezing, itching of the nose orthroat and itchywatery eyes due to hay fever. Temporary relieves cough due to minor throat and bronchial irritation as may occur with the common cold. temporary restores freer breathing through the nose.

Section 50566-9

Stop use and ask a doctor if:

You get nervous, dizzy, or sleepless.

Cough last more than 7 days, comes back, or is accompanied by fiver, rash or persistent headaches. These could be signs of a serious condition.

Section 50567-7

When using this product do not exceed recommended dosage

may cause marked drowsiness, avoid alcoholic beverages

alcohol, sedatives and tranquilizers may cause increased drowsiness

be carefulwhen driving a motor vehicleor operating machinery

excitability may occur, especially with children

Section 50569-3

Ask a Doctor Before use if you have

heart disease, thyroid disease trouble urinating due to enlarged prostate gland, glaucoma, cough that occurs with too much phlegm (mucus), a breathing problems or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Section 51945-4

Dometuss

Antihistamine/Cough Suppressant/Nasal Decongestant

Sugar, Alcohol, And Dye

Free

Grape Flavor

4 fl oz ( 118 ml)

Section 55105-1

Anthistamine

cough suppresant

nasal descongestant.

Use

For temporary relief of runny nose, sneezing, itching of the nose orthroat and itchywatery eyes due to hay fever.

Temporary relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

temporary restores freer breathing through the nose.

Section 55106-9

Active Ingredients ( in each 5ml-teaspoonful)

Chlorpheniramine Maleate 2mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Keep Out

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a poison Control center right away.

Question

Questions or Comments? Please call (787)767-3246.

Directions

Directions:

Do not exceed more than 6 doses in a 24 hour period.

Adults and children 12 years of age and over 2 teaspoonful (10 ml) every 4 hours.

Children 6 to under 12 years of age 1 teaspoonful (5 ml) every 4 hours.

Children under 6 years of age Ask a doctor.

If Pregnant

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

Tamper Evident

Tamper-Evident Disclosure: Do not use this product if aluminum foil over bottle opening is torn, broken or missing.

Other Information

Other information: store at room temperature between 15-30 C( 59-86 F)

Inactive Ingredients

Inactive ingredients:

Citric Acid, flavor, methylparaben, propylparaben, propylene glycol, purified water, sodium citrate and sucralose.

Indication and Usage Section

:

Indication and usage section:

adults and children 12 year of age and over--- 2 teaspoonful (10ml) every 4 hours

Childrens 6 to under 12 years of age------ i teaspoonful (5ml) every 4 hours

Childrens under 6 years of age------ask a doctor

Do not exceed more than 6 doses in any 24 hours period.


Structured Label Content

Warnings and Precautions (34071-1)

Warnings: Do not use

  • To sedate a child or to make a child sleepy.
  • If you are now taking a prescription monoamine oxidose inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditiosn 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, asl a doctor or pharmacist before taking this product.
Section 50566-9 (50566-9)

Stop use and ask a doctor if:

You get nervous, dizzy, or sleepless.

Cough last more than 7 days, comes back, or is accompanied by fiver, rash or persistent headaches. These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

may cause marked drowsiness, avoid alcoholic beverages

alcohol, sedatives and tranquilizers may cause increased drowsiness

be carefulwhen driving a motor vehicleor operating machinery

excitability may occur, especially with children

Section 50569-3 (50569-3)

Ask a Doctor Before use if you have

heart disease, thyroid disease trouble urinating due to enlarged prostate gland, glaucoma, cough that occurs with too much phlegm (mucus), a breathing problems or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Section 51945-4 (51945-4)

Dometuss

Antihistamine/Cough Suppressant/Nasal Decongestant

Sugar, Alcohol, And Dye

Free

Grape Flavor

4 fl oz ( 118 ml)

Section 55105-1 (55105-1)

Anthistamine

cough suppresant

nasal descongestant.

Use

For temporary relief of runny nose, sneezing, itching of the nose orthroat and itchywatery eyes due to hay fever.

Temporary relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

temporary restores freer breathing through the nose.

Section 55106-9 (55106-9)

Active Ingredients ( in each 5ml-teaspoonful)

Chlorpheniramine Maleate 2mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Keep Out

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a poison Control center right away.

Question

Questions or Comments? Please call (787)767-3246.

Directions

Directions:

Do not exceed more than 6 doses in a 24 hour period.

Adults and children 12 years of age and over 2 teaspoonful (10 ml) every 4 hours.

Children 6 to under 12 years of age 1 teaspoonful (5 ml) every 4 hours.

Children under 6 years of age Ask a doctor.

If Pregnant (If pregnant)

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

Tamper Evident (Tamper-Evident)

Tamper-Evident Disclosure: Do not use this product if aluminum foil over bottle opening is torn, broken or missing.

Other Information (Other information)

Other information: store at room temperature between 15-30 C( 59-86 F)

Inactive Ingredients

Inactive ingredients:

Citric Acid, flavor, methylparaben, propylparaben, propylene glycol, purified water, sodium citrate and sucralose.

Indication and Usage Section (Indication and usage section)

:

Indication and usage section:

adults and children 12 year of age and over--- 2 teaspoonful (10ml) every 4 hours

Childrens 6 to under 12 years of age------ i teaspoonful (5ml) every 4 hours

Childrens under 6 years of age------ask a doctor

Do not exceed more than 6 doses in any 24 hours period.


Advanced Ingredient Data


Raw Label Data

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