HISTEX-PE description, usages, side effects, indications, overdosage, supplying and lots more!

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HISTEX-PE

Allegis Pharmaceuticals, LLC

HISTEX™-PE Syrup


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients (in each 5 mL teaspoonful) Purpose
Phenylephrine HCl 10 mg Decongestant
Triprolidine HCl 2.5 mg Antihistamine

HISTEX-PE Uses

temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

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

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

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • new symptoms occur

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

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.

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

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 28595-803-16

Antihistamine • Decongestant

HISTEX-PE
Syrup

Each teaspoonful (5 mL)
contains:

Phenylephrine HCl
10 mg
Triprolidine HCl
2.5 mg

Sugar-Free • Dye Free
Alcohol Free

Grape Flavor

16 fl oz (473 mL)

HISTEX-PE

HISTEX-PE

PHENYLEPHRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:28595-803
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg
triprolidine hydrochloride TRIPROLIDINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:28595-803-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-03-17


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Be sure to consult your doctor before taking any medication!
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