DOMETUSS-NR- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

DOMETUSS-NR by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug FactsActive ingredients (in each tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 2 mg

Phenylephrine HCL 5 mg

Purpose

Analgesic, Fever reducer

Antihistamine

Nasal Decongestant

Keep out of reach of children.

Keep out of reach of children.

Uses

• Temporarily relieves nasal congestion due to the common cold
• sneezing
• runny nose
• itchy
• watery eyes due to hay fever
• itching of the nose and throat
• sinus congestion and pressure
• minor aches and pains associated with headache
• temporarily reduces fever.

Warniings

• Do not exceed the recommended dosage
• 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 8 tablets in 24 hours, which is the maxium daily allowance.
• with other drugs containing acetaminophen

Do not use

• 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), If you are not sure whether a drug contains aetaminophen, 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

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma or difficulty in urination due to enlargement of the prostate gland
• shortness of breath
• asthma
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• liver disease
• if you are taking the blood thinning drug warfarin.

Ask a doctor or pharmacist before use if you are taking:

• sedatives or tranquilizers
• other products containing acetaminophen

Stop using this product and ask a doctor if:

• new symptoms occur
• symptoms do not improve within 7 days or are accompanied by fever.
• nervousness, dizziness, or sleeplessness occurs
• pain or fever persists or get worse. 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 everages while taking this product
• Use caution when driving motor vehicle or operating machinery.

Overdose Warning:

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,

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: 2 tablets 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:

 magnesium stearate, povidone, pregelatinized starch, silicon dioxide, sodium carboxymethyl starch, stearic acid.

Questions or comments?

Please call (787) 767 3246

Domel Dometuss-NR product label

NDC: 53809-204-04

DOMETUSS-NR

ACETAMINOPHEN/CHLORPHENIRAMINE

MALEATE/PHENYLEPHRINE HCL

• Analgesic
• Fever Reducer
• Antihistamine
• Nasal Decongestant

4 TABLETS

Rev: 10/14

Lot #:

Exp:

Manufactured for:

DOMEL PHARMA

San Juan, Puero Rico, 00924

INGREDIENTS AND APPEARANCE

DOMETUSS-NR 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53809-204
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

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: 53809-204-04	4 in 1 PACKAGE; Type 0: Not a Combination Product	01/21/2016
2	NDC: 53809-204-01	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)