M-END PE- codeine phosphate, phenylephrine hydrochloride, brompheniramine maleate 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)

Brompheniramine Maleate 1.33 mg

Codeine Phosphate 6.33 mg

(WARNING: May be habit-forming)

Phenylephrine Hydrochloride 3.33 mg

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Uses

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

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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• chronic pulmonary disease or shortness of breath, or children who are taking other drugs
• 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 sedatives or tranquilizers.

When using this product

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

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.
• new symptoms occur

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 right away.

Directions

Do not exceed recommended dosage.

• Adults and children 12 years of age and over:

  3 teaspoonfuls every 4 to 6 hours,

  not to exceed 18 teaspoonfuls in a

  24 hour period

• Children 6 to under 12 years of age:

  1 1/2 teaspoonfuls every 4 to 6 hours,

  not to exceed 9 teaspoonfuls in a

  24 hour period

• Children under 6 years of age: Not recommended for use

A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

citric acid, cotton candy flavor, FD&C Red #40, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol

Questions? Comments?

Call 1-423-493-9170

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 354 mL label:

NDC: 12830-0754-12

M-END PE

Antihistamine · Antitussive

· Nasal Decongestant

Sugar Free · Alcohol Free

CV

EACH 5 mL (1 TEASPOONFUL)

CONTAINS:

Brompheniramine Maleate ..........................1.33 mg

Codeine Phosphate.......................................6.33 mg
(WARNING: May be habit-forming.)

Phenylephrine Hydrochloride.......................3.33 mg

Cotton Candy Flavor
12 fl. oz. (354 mL)

Mfg. for:

R.A. McNeil Company
Chattanooga, TN 37406-3738

Rev. 10/14

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

This package not intended for dispensing to the patient.

INGREDIENTS AND APPEARANCE

M-END   PE
codeine phosphate, phenylephrine hydrochloride, brompheniramine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12830-754
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	6.33 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	3.33 mg  in 5 mL
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1.33 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)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12830-754-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/19/2014
2	NDC: 12830-754-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/19/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/11/2008

Labeler - R.A. McNeil Company (008305220)

Registrant - Woodfield Pharmaceutical, LLC (079398730)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(12830-754)