Principal Display Panel - 30 Ml Bottle Label

Principal Display Panel - 30 Ml Bottle Label
SPL v5
SPL
SPL Set ID 0a55c379-ac91-461f-bdbe-1a4af39d68d4
Route
ORAL
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Drug Facts


Medication Information

Warnings and Precautions

Do not exceed recommended dosage.

Indications and Usage

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

Dosage and Administration

Do not exceed recommended dosage. For dosing, use only the enclosed dropper and not with any other drug product. AGE DOSE Adults & Children 12 years of age or older: 2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Store at 15°-30° C (59°-86° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.

Section 50565-1

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

new symptoms occur

Section 50567-7

excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase the drowsiness effect

Section 50569-3

a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor before use if the child is taking sedatives or tranquilizers

Section 51727-6

bubble gum flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose.

Section 51945-4

NDC 28595-801-30 HISTEX™ PD Drops Antihistamine Each dropperful (1 mL) contains: Triprolidine HCl 0.938 mg Sugar-Free • Dye Free Alcohol Free Bubble Gum Flavor 1 fl oz (30 mL)

Section 53413-1

Call 1-866-633-9033.

Section 55105-1

Antihistamine

Section 55106-9

Triprolidine HCl 0.938 mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Do not exceed recommended dosage. For dosing, use only the enclosed dropper and not with any other drug product. AGE DOSE Adults & Children 12 years of age or older: 2.67 mL (2.5 milligrams) every 4 to 6 hours, not to exceed 10.67 mL (10 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1.33 mL (1.25 milligrams) every 4 to 6 hours, not to exceed 5.33 mL (5 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

Warnings and Precautions (34071-1)

Do not exceed recommended dosage.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Store at 15°-30° C (59°-86° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.

Section 50565-1 (50565-1)

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

new symptoms occur

Section 50567-7 (50567-7)

excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase the drowsiness effect

Section 50569-3 (50569-3)

a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor before use if the child is taking sedatives or tranquilizers

Section 51727-6 (51727-6)

bubble gum flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sucralose.

Section 51945-4 (51945-4)

NDC 28595-801-30 HISTEX™ PD Drops Antihistamine Each dropperful (1 mL) contains: Triprolidine HCl 0.938 mg Sugar-Free • Dye Free Alcohol Free Bubble Gum Flavor 1 fl oz (30 mL)

Section 53413-1 (53413-1)

Call 1-866-633-9033.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Triprolidine HCl 0.938 mg


Raw Label Data

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