Principal Display Panel - 30 Ml Bottle Carton

Principal Display Panel - 30 Ml Bottle Carton
SPL v4
SPL
SPL Set ID 55a1a577-93af-4f4e-8858-430f4e2f6e56
Route
ORAL
Published
Effective Date 2023-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Drug Facts


Medication Information

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. use only the enclosed dropper. do not use enclosed dropper for any other drug products. AGE DOSE Adutls & Children 12 years of age or older: 2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor. Children 6 to under12 years of age: 1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor. Children under 6 years of age: Consult a docotor.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 43683-2

The Direction section has been updated with new dosage information. Inactive ingredients section has been updated to reflect the change in two ainactive ingredients

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

Stop use and ask a doctor if new symptoms occur

Section 50567-7

When using this product excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase the drowsiness effect

Section 50568-5

Ask a doctor before use if the child is taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if the child has a breathing problem such as emphysema or chronic bronchitis glaucoma

Section 50570-1

Do not exceed recommended dosage.

Section 51727-6

bubble gum flavor, citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Section 51945-4

NDC 28595-808-30 HISTEX™ PDX Drops Antihistamine Each dropperful (1 mL) contains: Triprolidine HCl 1.25 mg Sugar-Free • Dye Free Alcohol Free Bubble Gum Flavor 1 fl oz (30 mL) Bottle

Section 53413-1

Call 1-866-633-9033.

Section 55105-1

Antihistamine

Section 55106-9

Triprolidine HCl 1.25 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. use only the enclosed dropper. do not use enclosed dropper for any other drug products. AGE DOSE Adutls & Children 12 years of age or older: 2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor. Children 6 to under12 years of age: 1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor. Children under 6 years of age: Consult a docotor.

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

The Direction section has been updated with new dosage information. Inactive ingredients section has been updated to reflect the change in two ainactive ingredients

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)

Stop use and ask a doctor if new symptoms occur

Section 50567-7 (50567-7)

When using this product excitability may occur, especially in children may cause drowsiness sedatives and tranquilizers may increase the drowsiness effect

Section 50568-5 (50568-5)

Ask a doctor before use if the child is taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if the child has a breathing problem such as emphysema or chronic bronchitis glaucoma

Section 50570-1 (50570-1)

Do not exceed recommended dosage.

Section 51727-6 (51727-6)

bubble gum flavor, citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Section 51945-4 (51945-4)

NDC 28595-808-30 HISTEX™ PDX Drops Antihistamine Each dropperful (1 mL) contains: Triprolidine HCl 1.25 mg Sugar-Free • Dye Free Alcohol Free Bubble Gum Flavor 1 fl oz (30 mL) Bottle

Section 53413-1 (53413-1)

Call 1-866-633-9033.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Triprolidine HCl 1.25 mg


Raw Label Data

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