DOMETUSS- chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

Dometuss by

Drug Labeling and Warnings

Dometuss by is a Otc medication manufactured, distributed, or labeled by Dextrum Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

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.

ACTIVE INGREDIENT

Active Ingredients ( in each 5ml-teaspoonful)

Chlorpheniramine Maleate 2mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

WARNINGS

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.

ASK DOCTOR

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.

WHEN USING

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

STOP USE

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.

If pregnant

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

Keep Out

Keep out of reach of children.

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

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.

Other information

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

Tamper-Evident

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

Inactive Ingredients

Inactive ingredients:

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

Question

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

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.

PRINCIPAL DISPLAY PANEL

Dometuss

Antihistamine/Cough Suppressant/Nasal Decongestant

Sugar, Alcohol, And Dye

Free

Grape Flavor

4 fl oz ( 118 ml)

INGREDIENTS AND APPEARANCE

DOMETUSS 
chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE MONOHYDRATE (UNII: X6JU3FX5UU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-002-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/21/2016

Labeler - Dextrum Laboratories, Inc (007392322)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories, Inc		007392322	manufacture(65852-002)