FDA Label for Triprolidine Hydrochloride
View Indications, Usage & Precautions
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Triprolidine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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.
Purpose
(in each 1 mL dropperful)
Triprolidine HCI 0.938 mg
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes
Warnings
Do not exceed recommended dosage.
Ask A Doctor Before Use If You Have
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
Ask A Doctor Before Use If You Are
taking sedatives or tranquilizers
When Using This Product
■ may cause drowsiness
■ excitability may occur, especially in children
■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect
■ avoid alcoholic beverages
■ use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
■ 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. (1-800-222-1222)
Directions
do not exceed recommended dosage.
■ use only with enclosed dropper
■ do not use enclosed dropper for any other drug product
| Age | Dose |
| adult and children 12 year of age or older: | 2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams) in 24 hours, or as directed by a doctor. |
| children 6 to under 12 years of age: | 1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams) in 24 hours, or as directed by a doctor. |
| children under 6 years of age: | consult a doctor |
Other Information
■ this packaging is child-resistant.
■ store at room temperature 15°-30°C (59°-86°F)
■ Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken
Inactive Ingredients
bubble gum flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose
Questions Or Comments?
Call 1-800-645-2158.
Principal Display Panel
NDC 0536-1257-75
Rugby
Triprolidine HCl
Antihistamine
0.938mg/1mL
Bubblegum Liquid
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