M-CLEAR WC- codeine phosphate, guaifenesin liquid
R.A. McNeil Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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M-CLEAR WC

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

M-Clear WC Labeling 1.jpg M-Clear WC Labeling 2.jpg

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12830-717-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2008	09/15/2023
2	NDC:12830-717-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2008	09/15/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/30/2008	09/15/2023

Labeler - R.A. McNeil Company (008305220)

Revised: 9/2023

Document Id: 05945975-5a6b-3505-e063-6294a90a3cbe

Set id: 903fe5b6-6c28-4b92-bdab-32389c10c25a

Version: 7

Effective Time: 20230917

R.A. McNeil Company