Triprolidine Hcl Drops
FDA Label NDC 15310-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Creekwood Pharmaceutical Inc. for the product Triprolidine Hcl Drops (NDC 15310-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other information, warnings, ask a doctor before use if the child has, do not use this product, stop use and ask a doctor if, keep out of reach of children., indications & usage, drug facts, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other Information

→ Warnings

→ Ask A Doctor Before Use If The Child Has

→ Do Not Use This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Indications & Usage

→ Drug Facts

→ Otc - Purpose

→ Directions

→ Inactive Ingredients

→ Questions Comments

→ Product Packaging

Other Information

Store at 59° - 86°F (15° - 30°C)

Warnings

Do not exceed recommended dosage.

Ask A Doctor Before Use If The Child Has

heart disease
high blood pressure
thyroid disease
diabetes
diffculty in urination due to the enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis
glaucoma

Do Not Use This Product

in a child who is 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 the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Stop Use And Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or are accompanies by fever

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Indications & Usage

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

Nasal Congestion
reduces swelling of nasal passages
runny nose
sneezing
itching of the nose or throat
itchy,watery eyes

Drug Facts

Active ingredients

(in each 1 mL dropperful)

Triprolidine Hydrochloride 0.938mg

Otc - Purpose

Purpose

Anitihistamine

Directions

Do Not exceed recommended dosage.

Use only with enclosed dropper. Do not use with any other device.


Adults and Children 12 years of age and over	2.67 mL every 4 hours to 6 hours,not to exceed 4 doses in 24 hours
Children 6 years to under 12 years of age:	1.33mL every 4 to 6 hours, not to exceed 4 doses in 24 hours
Children under 6 years of age:	Consult a doctor.

Inactive Ingredients

Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Sucralose.

Questions Comments

Seek medical assistance immediately for serious side effects associated with the use of this product. Serious side effects may be reported to this number: 866-991-9870 ( mon-Fri 8 a.m to 5 p.m EST)