Label: TRIPROLIDINE HCL DROPS liquid
- NDC Code(s): 15310-112-42
- Packager: Creekwood Pharmaceutical Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 2, 2021
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- Official Label (Printer Friendly)
- Other information
Do not exceed recommended dosage.
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diffculty in urination due to the enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
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
- INDICATIONS & USAGE
- Drug Facts
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
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
- Questions Comments
The packaging below represents the labeling currently used.
Principal display panel and side panel for 30 mL label:
Triprolidine HCl Drops
Alllergic Rhintis, Respiratory Allergies & Nasal Decongestant
Alcohol-Free · Dye Free · Sugar Free · · Cotton Candy Flavor
Each Dropperful (1 mL) contains:
Triprolidine HCl, USP..........................0.938 mg
Net Wt. 1 FL OZ (30 mL)
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
951 Clint Moore Road,
Boca Taton, FL 33487
INGREDIENTS AND APPEARANCE
TRIPROLIDINE HCL DROPS
triprolidine hcl drops liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15310-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 0.938 mg in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor COTTON CANDY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15310-112-42 1 in 1 BOX 12/06/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/06/2019 Labeler - Creekwood Pharmaceutical Inc. (618997188) Establishment Name Address ID/FEI Business Operations Woodfield Pharmaceutical, LLC 079398730 manufacture(15310-112)