HISTEX AC- codeine phosphate, phenylephrine hydrochloride, and triprolidine hydrochloride syrup

HISTEX AC by

Drug Labeling and Warnings

HISTEX AC by is a Otc medication manufactured, distributed, or labeled by Allegis Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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.

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:	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)

INGREDIENTS AND APPEARANCE

HISTEX AC 
codeine phosphate, phenylephrine hydrochloride, and triprolidine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28595-250
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28595-250-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/12/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/12/2015

Labeler - Allegis Pharmaceuticals, LLC (792272861)