HISTEX AC- codeine phosphate, phenylephrine hydrochloride, and triprolidine hydrochloride syrup 
Allegis Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

HISTEX™ AC Syrup

Drug Facts

Active ingredients (in each 5 mL teaspoonful)Purpose
Codeine Phosphate 10 mgAntitussive
Phenylephrine HCl 10 mgNasal Decongestant
Triprolidine HCl 2.5 mgAntihistamine

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
  • cough due to minor throat and bronchial
  • irritation
  • 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

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

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • may cause or aggravate constipation
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • 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.

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 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:Not recommended for use.

Other information

Store at 15°-30°C (59°-86°F).

Inactive ingredients

Bubble Gum Flavor, Citric Acid, Methylparaben, Potassium Citrate, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose.

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 28595-250-16

Antihistamine • Antitussive
Nasal Decongestant

HISTEX™-AC
Syrup

Each teaspoonful (5 mL)
contains:

Codeine Phosphate  10 mg
Phenylephrine HCl  10 mg
Triprolidine HCl  2.5 mg

Sugar-Free • Dye Free
Alcohol Free
Bubble Gum Flavor

Tamper evident by foil seal under cap.
Do not use If foil seal is broken or missing.

Caution: For manufacturing, processing, or
repackaging. This is a bulk container; not
intended for household use.

16 fl oz (473 mL)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
HISTEX AC 
codeine phosphate, phenylephrine hydrochloride, and triprolidine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-250
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:28595-250-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/12/201502/28/2022
Labeler - Allegis Pharmaceuticals, LLC (792272861)

Revised: 12/2022
 
Allegis Pharmaceuticals, LLC