Country: United States
Language: English
Source: NLM (National Library of Medicine)
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)
Monarch PCM, LLC
ORAL
OTC DRUG
Antihistamine 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
OTC monograph final
TRIPROLIDINE HYDROCHLORIDE- TRIPROLIDINE HYDROCHLORIDE LIQUID MONARCH PCM, LLC _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._ ---------- TRIPROLIDINE HCI _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. 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 WHEN USING THIS PRODUCT excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase the drowsiness effect STOP USE AND ASK A DOCTOR IF new symptoms occur 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, c Read the complete document