Active ingredientCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE
Label structure12 sections
Dosage and administration
Directions Do not exceed recommended dosage. Use calibrated measuring device for administering the drug to a child. Adults and children 12 years of age and over: 2 teaspoonfuls (10 ml) every 6 to 8 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 teaspoonful (5 ml) every 6 to 8 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a d...
Active ingredients (in each 5 ml) Purpose Chlophedianol HCI 12.5 mg ..................................... Antitussive
Pyrilamine Maleate 12.5 mg ................................. Antihistamine
Purpose
OTC - PURPOSE SECTION
Antitussive
Antihistamine
INDICATIONS & USAGE SECTION
Uses 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
calms the cough control center and relieves coughing
runny nose
sneezing
itching of the nose and throat
itchy, watery eyes
WARNINGS SECTION
WARNINGS Do not exceed recommended dosage
DO NOT USE IF PRINTED SAFETY SEAL IS MISSING OR BROKEN
If you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions or Parkinsons disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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)
Ask a doctor or pharmacist before us if you are:
Taking sedatives or tranquilizers
If you have a breathing problem such as emphysema or chronic bronchitis
If you have glaucoma
If you have difficult in urination due to enlargement of the prostate gland
OTC - WHEN USING SECTION
When using this product
Excitability may occur, especially in children
Marked drowsiness may occur
Avoid alcoholic drinks
Alcohol, sedatives, and tranquilizers may increase the drowsiness effect
Be careful when driving a motor vehicle or operating machinery
OTC - DO NOT USE SECTION
Stop use and ask a doctor if
Nervousness, dizziness, or sleeplessness occurs
Symptoms do not improve within 7 days or are accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
New symptoms occur
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding
Ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Dosage and Administration
DOSAGE & ADMINISTRATION SECTION
Directions
Do not exceed recommended dosage. Use calibrated measuring device for administering the drug to a child.
Adults and children
12 years of age
and over:
2 teaspoonfuls (10 ml) every 6 to 8
hours, not to exceed 6 teaspoonfuls in
24 hours, or as directed by a doctor.
Children 6 to under
12 years of age:
1 teaspoonful (5 ml) every 6 to 8 hours,
not to exceed 3 teaspoonfuls in 24 hours,
or as directed by a doctor.
Children under
6 years of age:
Consult a doctor.
Other Information Store at 20° -25°C (68°-77°F); excursions permitted to 15°-30°C (59° - 86°F). [See USP Controlled Room Temperature].
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
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