ENDACOF DM- brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

EndaCof DM by

Drug Labeling and Warnings

EndaCof DM by is a Otc medication manufactured, distributed, or labeled by Larken Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

(In each 5 mL teaspoonful)

Brompheniramine Maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Brompheniramine Maleate Antihistamine

Dextromethorphan HBr Antitussive (cough suppressant)

Phenylephrine HCl Nasal decongestant

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis):

• cough due to minor throat and bronchial irritation
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• temporarily restores freer breathing through the nose

Warnings

Do not use

• to sedate a child or 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 drug.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

• taking any other nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product

Do not exceed recommended dosage.

• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur.
• cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of the reach of children

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

Do not exceed 6 doses in a 24-hour period

• Age: Dose
• Adults and children over 12 years of age: 4 teaspoonsful (20 mL) every 4 hours
• Children 6 to under 12 years of age: 2 teaspoonsful (10 mL) every 4 hours
• Children under 6 years of age: Ask your doctor

Other Information

• store at 20°-25°C (68°-77°F)
• very low sodium, contains 1 mg sodium per teaspoonful (5 mL)

Inactive Ingredients

Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring

Questions or Comments

Call 1-888-527-5522 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

Principal Display Panel

Figure 1: 16 oz. Bottle Label

INGREDIENTS AND APPEARANCE

ENDACOF DM 
brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68047-143
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68047-143-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/30/2012

Labeler - Larken Laboratories, Inc. (149484540)

Registrant - Larken Laboratories, Inc. (149484540)