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M-END

R.A. McNeil Company
Pernix Manufacturing, LLC

M-END PE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Codeine Phosphate 6.33 mg
(WARNING:  May be habit-forming)
Phenylephrine Hydrochloride 3.33 mg
Brompheniramine Maleate 1.33 mg

Purpose

Cough Suppressant

Nasal Decongestant

Antihistamine

M-END 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
  • swelling of nasal passages
  • runny nose
  • itchy, watery eyes
  • sneezing

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
  • 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

  • you may get drowsy
  • avoid alcoholic drinks
  • 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.
  • 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

   

M-END 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

CV

EACH 5 mL (1 TEASPOONFUL)

CONTAINS:

Codeine Phospate.......................................6.33 mg
(WARNING:  May be habit-forming.)
Phenylephrine Hydrochloride.......................3.33 mg
Brompheniramine Maleate ..........................1.33 mg


12 fl. oz. (354 mL)

Mfg. for:

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

Rev. 9/08

Tamper evident by foil seal under cap. 

Do notuse if foil seal is broken or missing.

This package not intended for dispensing to the patient.

M-END

M-END

M-END

Codeine Phosphate, Phenylephrine Hydrochloride, Brompheniramine Maleate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:12830-754
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE CODEINE ANHYDROUS 6.33 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 3.33 mg
Brompheniramine Maleate BROMPHENIRAMINE 1.33 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12830-754-12 354 in 1 BOTTLE
2 NDC:12830-754-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-11-11


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Be sure to consult your doctor before taking any medication!
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