FDA Label for Poly-tussin Ac
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOONFUL)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE THIS PRODUCT
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF THE REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS? COMMENTS?
- PRODUCT PACKAGING:
Poly-tussin Ac Product Label
The following document was submitted to the FDA by the labeler of this product Poly Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 5 Ml Teaspoonful)
Brompheniramine Maleate 4 mg
Codeine Phosphate 10 mg
Phenylephrine Hydrochloride 10 mg
Purpose
Antihistamine
Antitussive
Decongestant
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, water eyes
- cough due to minor throat and bronchial irritation
- nasal congestion
- reduces swelling of the nasal passages
Warnings
Do not exceed recommended dosage.
Do Not Use This Product
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping
Ask A Doctor Before Use If You Have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to the enlargement of the prostate gland
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm
a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
heart disease
high blood pressure
thyroid disease
diabetes
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- may cause or aggravate constipation
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
nervousness, dizziness, or sleeplessness occur
cough or nasal congestion 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.
new symptoms occur
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of The 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 over 12
years of age: | 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed
6 teaspoonfuls in a 24 hour period. |
Children 6 to under 12 years of age:
| 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed
3 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
Bubble gum flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, raspberry flavor, sorbitol, sucralose.
Questions? Comments?
Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041
Mon - Fri (8a.m. to 5 p.m. CST)
Product Packaging:
Packaging below represents label currently used:
Principal display panel and side panel for 473 mL label:
NDC 50991-723-16
POLY-TUSSIN AC LIQUID
Antihistamine/Antitussive/Decongestant
Alcohol Free/Dye Free
NEW FORMULA
Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate......................................4 mg
Codeine Phosphate..............................................10 mg
Phenylephrine HCl.............................................. 10 mg
Raspberry-Bubble Gum Flavor
CV
Rx Only
Distributed by:
Poly Pharmaceuticals
Huntsville, AL 35763
16 fl oz. (473 mL)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Dispense in a tight, light-resistant container with a child-resistant closure.
This bottle is not to be dispensed to consumer.
* Please review the disclaimer below.