M-CLEAR WC- codeine phosphate, guaifenesin liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)

Available from:

R.A. McNeil Company

INN (International Name):

CODEINE PHOSPHATE

Composition:

CODEINE PHOSPHATE 6.33 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

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