DOMETUSS-NR- dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride tablet

DOMETUSS-NR by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)		Purpose
Dextromethorphan HBr	20 mg	Cough Suppressant
Chlorpheniramine Maleate	4 mg	Antihistamine
Phenylephrine HCl	10 mg	Nasal decongestant

Uses

• Temporarily relieves
  • runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever.
  • Nasal congestion due to the common cold.
  • coughs due to minor throat and bronchial irritation as may occur with a cold.

Warnings

• Do not exceed recommended dosage

Do not use

• if you are now taken 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.

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 problem 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.

Stop using this product and ask a doctor if

• you get nervous, dizzy or sleepless
• cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headaches, these could be signs of a serious condition.

When using this product

• Excitability may occur, especially in children
• May cause drowsiness
• alcohol, sedatives and tranquilizers may increase the drowsiness effect
• Avoid alcoholic beverages while taking this product
• Use caution when driving motor vehicle or operating machinery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults even if you do not notice signs or symptoms.

If you are pregnant or breast-feeding, ask a health professional before use.

Directions

Do not take more than 6 tablets in 24 hours, or as directed by a doctor.

Age	Dose
adults and children 12 years of age and over	1 tablet every 4 hours.
children under 12 years of age	Consult a doctor before use.

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

Carbomer, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Talc.

Questions or comments?

Please call (787) 767-3246

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC: 53809-240-01

DOMETUSS-NR

DEXTROMETHORPHAN HBr/ CHLORPHENIRAMINE
MALEATE/ PHENILEPHRINE HCl

• Cough Suppressant
• Antihistamine
• Nasal decongestant

100 TABLETS

INGREDIENTS AND APPEARANCE

DOMETUSS-NR 
dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53809-240
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	KL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53809-240-01	100 in 1 BOTTLE; 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 final	part341	01/21/2016

Labeler - Domel Laboratories (808198837)

Establishment
Name	Address	ID/FEI	Business Operations
Lex Inc		046172888	MANUFACTURE(53809-240)