TRIPROLIDINE HYDROCHLORIDE liquid

TRIPROLIDINE HYDROCHLORIDE by

Drug Labeling and Warnings

TRIPROLIDINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Strides Pharma Inc, Strides Pharma Science Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each mL)

Triprolidine HCl USP 0.625 mg

Purpose

Antihistamine

Uses

• temporarily relieves:
  • runny nose
  • sneezing
  • itching of nose and throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis

Warnings

• May cause excitability, especially in children

Do Not Use

• if you or your children are taking sedatives or tranquilizers, without first consulting your doctor
• with any other product containing triprolidine

Ask a doctor before use if your child has

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland

When using this product

• do not use more than directed
• may cause drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if:

• nervousness, dizziness or sleeplessness occurs
• symptoms do not improve within 7 days or are accompanied by a fever

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

Directions

• take every 6 hours
• do not take more than 4 doses in 24 hours or as directed by a doctor.
• do not give more than directed or exceed the recommended daily dosage
• use only enclosed dropper
• do not use enclosed dropper for any other drug product

• Adults and children 12 years of age and over: 4 mL (2.5 mg)
• Children 6 to under 12 years of age: 2 mL (1.25 mg)
• Children under 6 years of age: ask a doctor

Other Information

• store at controlled room temperature 15°-30°C (59°-86°F)
• Tamper Evident: Do not use if seal is broken or missing.

Inactive Ingredients

Bubble Gum Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions?

Call 1-877-244-9825

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC 59556-896-59

Triprolidine Hydrochloride Oral Solution USP

Each 1 mL contains:

Triprolidine HCl USP….. 0.625 mg

Antihistamine

1 oz. (30 mL)

Bubble Gum Flavor

Tamper Evident: Do not use If seal is broken or missing.

Strides Pharma Inc.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

NDC 59556-896-89

Triprolidine Hydrochloride Oral Solution USP

Each 1 mL contains:

Triprolidine HCl USP….. 0.625 mg

Antihistamine

50 mL

Bubble Gum Flavor

Tamper Evident: Do not use If seal is broken or missing.

Strides Pharma Inc.

INGREDIENTS AND APPEARANCE

TRIPROLIDINE HYDROCHLORIDE 
triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59556-896
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	0.625 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59556-896-89	1 in 1 CARTON	05/21/2019
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 59556-896-59	1 in 1 CARTON	05/21/2019
2		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	05/21/2019

Labeler - Strides Pharma Inc (078868278)

Establishment
Name	Address	ID/FEI	Business Operations
Strides Pharma Science Limited		918513263	ANALYSIS(59556-896) , MANUFACTURE(59556-896) , PACK(59556-896)