Label: TRIPROLIDINE HYDROCHLORIDE liquid
- NDC Code(s): 70154-204-30
- Packager: Monarch PCM, LLC
- 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 January 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 1 mL dropperful)
- Purpose
- Uses
-
Warnings
Do not exceed recommended dosage.
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
-
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
- Inactive ingredients
- Questions? Comments?
-
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 -
INGREDIENTS AND APPEARANCE
TRIPROLIDINE HYDROCHLORIDE
triprolidine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70154-204 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) POTASSIUM CITRATE (UNII: EE90ONI6FF) AMMONIUM GLYCYRRHIZINATE TRIHYDRATE (UNII: 78NEL3149I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70154-204-30 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M012 08/19/2019 10/31/2024 Labeler - Monarch PCM, LLC (080000294)