M-END DMX- dexbrompheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid

M-END by

Drug Labeling and Warnings

M-END by is a Otc medication manufactured, distributed, or labeled by R. A. McNeil Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Dexbrompheniramine Maleate 0.667 mg
Dextromethorphan HBr 10 mg
Pseudeophedrine HCl 20 mg

Purpose

Antihistamine

Antitussive

Cough Suppressant

Nasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• cough due to minor throat and bronchial irritation
• nasal congestion
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

• 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

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizes may increase the drowsiness effect
• be careful when driving a motor vehicle or operating machinery
  

Stop use and ask a doctor if

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

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

Keep out of reach of children.

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

Directions

Do not exceed 4 doses in a 24 hour period.

• Adults and children 12 years of age and over: 3 teaspoonfuls (15 mL) ; every 6 hours, not to ; exceed 12 teaspoonfuls ; in 24 hours
• Children 6 to under 12 years of age: 1 1/2 teaspoonfuls ; (7.5 mL) every 6 hours, ; not to exceed 6 ; teaspoonfuls in ; 24 hours
• Children under 6 years of age: Consult a Physician.

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

Bitter Mask, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose, Tutti Frutti Flavor.

Questions? Comments?

Call 1-423-493-9170

Product Packaging

INGREDIENTS AND APPEARANCE

M-END   DMX
dexbrompheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12830-816
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	0.667 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	20 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12830-816-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/13/2011
2	NDC: 12830-816-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/13/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/13/2011

Labeler - R. A. McNeil Company (008305220)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceuticals, Inc.		079398730	manufacture(12830-816)