1. Home
  2. Labeler Index
  3. Allegis Pharmaceuticals, Llc
  4. 28595-804
  5. Label Information: Histex-dm

FDA Label for Histex-dm

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS? COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

Histex-dm Product Label

The following document was submitted to the FDA by the labeler of this product Allegis Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each 5 mL teaspoonful)Purpose
Dextromethorphan HBr 20 mgCough Suppressant
Phenylephrine HCl 10 mgDecongestant
Triprolidine HCl 2.5 mgAntihistamine

Uses



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

  • cough due to minor throat or bronchial irritation
  • 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
  • a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • 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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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.

AGEDOSE
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 age½ 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 ageConsult 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 28595-804-16

Antihistamine • Decongestant
Cough Suppressant

HISTEX™-DM
Syrup

Each teaspoonful (5 mL)
contains:
Dextromethorphan HBr  20 mg
Phenylephrine HCl         10 mg
Triprolidine HCl            2.5 mg

Sugar-Free • Dye Free
Alcohol Free

Grape Flavor

16 fl oz (473 mL)

Principal Display Panel - 473 mL Bottle Label - histex 01

Principal Display Panel - 473 mL Bottle Label - histex 01


* Please review the disclaimer below.