M-CLEAR WC- codeine phosphate, guaifenesin liquid

M-CLEAR by

Drug Labeling and Warnings

M-CLEAR 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)
Codeine Phosphate* 6.33 mg
*WARNING:  May be habit-forming

Guaifenesin 100 mg

Purpose

Antitussive

Expectorant

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

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

INGREDIENTS AND APPEARANCE

M-CLEAR   WC
codeine phosphate, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12830-717
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 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: 12830-717-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2008
2	NDC: 12830-717-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/30/2008

Labeler - R.A. McNeil Company (008305220)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(12830-717)