DOMETUSS- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup

DOMETUSS by

Drug Labeling and Warnings

DOMETUSS by is a Otc medication manufactured, distributed, or labeled by Domel Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 ml-teaspoonful)	Purpose
Chlorpheniramine Maleate 4 mg	Antihistamine
Dextromethorphan HBr 20 mg	Cough suppressant
Phenylephrine HCl 10 mg	Nasal Decongestant

USE

• For temporary relief of runny nose, sneezing,itching of the nose or throat and itchy watery eyes due to hay fever.
• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
• Temporarily restores freer breathing through the nose

WARNINGS

DO NOT USE

• to sedate a child or to make a child sleepy
• If you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

• taking sedatives or tranquilizers

• 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 careful when driving a motor vehicle or operating machinery
• excitability may occur, especially with children.

STOP USE AND ASK A DOCTOR IF

you get nervous, dizzy, or sleepless.

• cough last more than 7 day, comes back, or is accompanied by fever, rash or persistent headaches. These could be signs of a serious condition.

IF PREGNANT OR BREAST FEEDING ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN. in case of accidental overdose, get medical help or contact a poison control Center right away.

Directions

Do not exceed more than 6 doses in any 24-hour period

• Adults and children 12 years of age and over: Take 1 teaspoonful (5 mL) every 4 hours
• Children 6 to under 12 years of age: Take 1/2 teaspoonful (2.5 mL) every 4 hours
• Children under 6 years of age: Ask a doctor

Other Information

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

Tamper-Evident Disclosure

Do not use this product if aluminum foil over bottle opening is torn, broken or missing.

Inactive ingredients

citric acid,grape flavor,glycerin hydroxyethylcellulose methylparaben,propylen glycol, propylparaben, purified water,sodiumcitrate,and sucralose.

Questions or comments?

Please call (787) 767-3246

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC: 53809-202-04

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 hydrobromide, and phenylephrine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53809-202
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53809-202-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/01/2015

Labeler - Domel Laboratories (808198837)