PRO-CLEAR AC- codeine phosphate and pyrilamine maleate syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520), Pyrilamine Maleate (UNII: R35D29L3ZA) (Pyrilamine - UNII:HPE317O9TL)

Available from:

Pro-Pharma LLC

INN (International Name):

Codeine Phosphate

Composition:

Codeine Phosphate 9 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

PRO-CLEAR AC- CODEINE PHOSPHATE AND PYRILAMINE MALEATE SYRUP
PRO-PHARMA LLC
_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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PRO-CLEAR AC SYRUP
DRUG FACTS
ACTIVE INGREDIENTS
(IN EACH 5 ML TEASPOONFUL)
Codeine Phosphate* 9 mg
*WARNING: May be habit forming.
Pyrilamine Maleate 8.33 mg
PURPOS E
Antitussive
Antihistamine
US ES
Temporarily relieves these symptoms due to the common cold, hay fever
(allergic rhinitis) or other
upper respiratory allergies:
cough due to minor throat and bronchial irritation
runny nose
sneezing
itching of the nose or throat
itchy, water eyes
WARNINGS
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
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or
tranquilizers.
WHEN USING THIS PRODUCT
may cause or aggravate constipation
excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness
effect
be careful when driving a motor vehicle or operating machinery
STOP USE AND ASK A DOCTOR IF
a cough persists for more than 1 week, tends to recur, or is
accompanied by a fever, rash, or
persistent headache. A persistent cough may be a sign of a serious
condition.
new symptoms occur
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
Do not exceed recommended dosage.
Adults and
children 12
years of
age
and over:
2 teaspoonfuls (10 mL)
every 4 hours, not to
e