FDA Label for Triprolidine Hydrochloride
View Indications, Usage & Precautions
Triprolidine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Monarch Pcm, Llc. 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.
Other
Drug Facts
Active Ingredients (In Each 1 Ml Dropperful)
Triprolidine HCl 0.938 mg
Purpose
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.
Otc - Ask Doctor
Ask a doctor before use if the child has
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
Ask a doctor before use if the child is taking sedatives or tranquilizers
Otc - When Using
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- sedatives and tranquilizers may increase the drowsiness effect
Otc - Stop Use
Stop use and ask a doctor if
- new symptoms occur
Otc - Keep Out Of Reach Of Children
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.
■ use only with enclosed dropper
■ do not use enclosed dropper for any other drug product
■ mL= milliliter
■ Professional Labeling: Take under guidance of Health Professionals.
| AGE | DOSE |
|---|---|
| Childen 4 to under 6 years of age: | 1 dropperful (1.0 mL) every 4 to 6 hours, not to exceed 4 doses (4.0 mL) in 24 hours, or as directed by a Doctor. |
| Children 2 to under 4 years of age | ⅔ dropperful (0.67 mL) every 4 to 6 hours, not to exceed 4 doses (2.67 mL) in 24 hours, or as directed by a Doctor. |
| Infants 4 months to under 2 years of age | ⅓ dropperful (0.33 mL) every 4 to 6 hours, not to exceed 4 doses (1.33 mL) in 24 hours, or as directed by a Doctor. |
Other Information
- 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? Comments?
Call 1-844-696-6627 9 a.m. - 5 p.m. CST.
Principal Display Panel - 30 Ml Bottle Carton
Do not use if foil seal
under cap is missing or
broken.
Usual Dosage:
See attached labeling for
complete product
information.
store at °30-15C
(°86-68F)
KEEP OUT OF REACH
OF CHILDREN.
This product
includes professional
labeling for medical
practioners only.
Manufactured by:
Monarch PCM, LLC.
Fort Worth, TX 76118
* Please review the disclaimer below.