FDA Label for Triponel
View Indications, Usage & Precautions
Triponel Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceuticals International Division. 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.
Otc - Active Ingredient
Active Ingredients (in each 5 mL)
Dextromethorphan HBr 15 mg
Phenylephrine HCl 5 mg
Triprolidine HCl 1.25 mg
Otc - Purpose
Purpose
Cough Suppressant
Nasal Decongestant
Antihistamine
Indications & Usage
Uses
- helps to control the reflex that causes coughing
- temporarily relieves nasal congestion due to common cold, hay fever, or other upper respiratory allergies (allergic, rhinitis)
- temporarily relieves these symptomes due to hay fever or ther upper respiratory allergies
- runny nose
- itchy, watery eyes
- sneexing
- itching of the nose or throat
Warnings
Warnings
Do not use if you are taking a monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you r prescirption drug contains an MAOI, ask a doctor or pharmacist before using this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of prostate gland
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
- do not exceed recommended dose
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- nervousness dizziness, or sleeplessness occurs
- cough lasts for more than 7 days, comes back, or occurs with a beer, rash, or headache that lasts. These could be signs of a serious condition.
Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.
When using this product
Stop use and ask a doctor if
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Direcations: Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.
| Age | Dose |
| Adults and children 12 years of age and over | Take 2 teaspoonfuls (10 mL) every 6 hours |
| Children 6 to under 12 years of age | Take 1 teaspoonful (5 mL) every 6 hours |
| Children under 6 | Ask a docotor |
Inactive Ingredient
Inactive ingredients: artificial flavor, citric acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.
Otc - Questions
Questions or Comments? 1-866-595-5598
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