Histex™ Syrup

Histex™ Syrup
SPL v4
SPL
SPL Set ID cc466d33-cf3e-4f1c-a794-6d3d79903adf
Route
ORAL
Published
Effective Date 2020-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Triprolidine (2.5 mg)
Inactive Ingredients
Sodium Benzoate Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Citrate, Unspecified Form Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-04

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

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 53414-9

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

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

AGE DOSE
Adults and Childen 12 years of age and older: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor
Childen 6 to under 12 years of age ½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor.
Children under 6 years of age Consult a doctor
Other Information

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.

Dispense in a tight, light-resistant container with a child-resistant cap.

Inactive Ingredients

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

Questions? Comments?

Call 1-866-633-9033.

When Using This Product
  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
  • new symptoms occur
Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

Active Ingredients (in Each 5 Ml Teaspoonful)

Triprolidine HCl 2.5 mg

Principal Display Panel 237 Ml Bottle Label

NDC 28595-802-08

Antihistamine

HISTEX™



Syrup

Each teaspoonful (5 mL)



contains:




Triprolidine HCl 2.5 mg

Sugar-Free • Dye Free



Alcohol Free

Bubble Gum Flavor

8 fl oz (237 mL)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

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 53414-9 (53414-9)

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

Purpose

Antihistamine

Warnings

Do not exceed recommended dosage.

Directions

Do not exceed recommended dosage.

AGE DOSE
Adults and Childen 12 years of age and older: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor
Childen 6 to under 12 years of age ½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor.
Children under 6 years of age Consult a doctor
Other Information

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.

Dispense in a tight, light-resistant container with a child-resistant cap.

Inactive Ingredients (Inactive ingredients)

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

Questions? Comments?

Call 1-866-633-9033.

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

Active Ingredients (in Each 5 Ml Teaspoonful) (Active ingredients (in each 5 mL teaspoonful))

Triprolidine HCl 2.5 mg

Principal Display Panel 237 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label)

NDC 28595-802-08

Antihistamine

HISTEX™



Syrup

Each teaspoonful (5 mL)



contains:




Triprolidine HCl 2.5 mg

Sugar-Free • Dye Free



Alcohol Free

Bubble Gum Flavor

8 fl oz (237 mL)


Advanced Ingredient Data


Raw Label Data

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