M-CLEAR description, usages, side effects, indications, overdosage, supplying and lots more!

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M-CLEAR

R.A. McNeil Company
Pernix Manufacturing, LLC

M-CLEAR WC


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

Guaifenesin 100 mg

Purpose

Antitussive

Expectorant

M-CLEAR Uses

temporarily relieves these symptoms due to the common cold:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • chronic pulmonary disease or shortness of breath, or children who are taking other drugs

Stop use and ask a doctor if

  • cough 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.
  • may cause or aggravate constipation
  • new symptoms occur

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

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children
12 years of age
and over:

3 teaspoonfuls (15 mL)
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
(7.5 mL) 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

M-CLEAR Other information

Store at 59°-86°F (15°-30°C)

Inactive ingredients

citric acid, cotton candy flavor, 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 473 mL label:

NDC 12830-0717-16


M-CLEAR WC

Antitussive / Expectorant

Sugar Free / Dye Free /

Alcohol Free

CV

EACH 5mL (1 TEASPOONFUL) CONTAINS:

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

Guaifenesin...................................................100 mg

Cotton Candy Flavor


ONE PINT (473 mL)

Mfg. for:  R.A. McNeil Company
Chattanooga, TN  37406-3738

Rev. 03/09

Tamper evident by foil seal under cap.  Do not
use if foil seal is broken or missing.

Supplied in a tight, light-resistant container

with a child-resistant cap.

This package not intended for dispensing to the patient.

Manufactured for:

R.A. McNeil Company

1150 Latta Street

Chattanooga, TN 37406-3738

Rev. 03/09



M-CLEAR

M-CLEAR

M-CLEAR

Codeine Phosphate, Guaifenesin LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:12830-717
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE CODEINE ANHYDROUS 6.33 mg
Guaifenesin GUAIFENESIN 100 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:12830-717-16 473 in 1 BOTTLE
2 NDC:12830-717-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2008-10-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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