OTC Medication Information: M-CLEAR WC

M-CLEAR WC- codeine phosphate and 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.

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

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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 (CODEINE ANHYDROUS) CODEINE PHOSPHATE 6.33 mg in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL
Product Characteristics
Color Score
Shape Size
Flavor COTTON CANDY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12830-717-16 473 mL in 1 BOTTLE None
2 NDC:12830-717-30 30 mL in 1 BOTTLE None
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 Operations
Woodfield Pharmaceutical, LLC 079398730 manufacture (12830-717)

Revised: 01/2020 R.A. McNeil Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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