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Entre-B

Generic Name: brompheniramine maleate and phenylephrine hydrochloride
Dosage Form: oral suspension

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Entre-B SUSPENSION 4 FL OZ (118 ML)

Entre-B    NDC 42192-513-04

Suspension

Antihistimine   Decongestant

Bubblegum Flavor



Each 5 mL (teaspoonful) contains:

Brompheniramine Maleate.............6mg

Phenylephrine HCL.......................10mg

Rx Only      Shake Well



DOSAGE AND ADMINISTRATION:
Adults and children over 12 years of age:
1 - 2 teaspoonfuls every 12 hours.
Children 6 to under 12 years of age:
1 teaspoonful every 12 hours.
Children under 6 years of age:
Consult a physician.
Dispense in a well closed, light-resistant container. Store at controlled room temperature, 20° - 25°C (68° - 77°F) [See USP].
Shake well before use.
WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
Utilizing Neuvosyn™ Technology

Entre-B Suspension Rx Only
Entre-B is an antihistamine/nasal decongestant combination for oral administration as a suspension.
Each 5 mL (one teaspoonful) of the bubble-gum flavored, suspension for oral administration contains:
Phenylephrine HCl .............................. 10 mg
Brompheniramine Maleate .................... 6 mg

INACTIVE INGREDIENTS: Propylene Glycol, Glycerin, Xanthan Gum, Bubble Gum Flavor, Saccharin Sodium, Sodium Citrate, Citric Acid, Tannic Acid, Magnesium Aluminum Silicate, Natural Masking Flavor, Pink Dye, Benzoic Acid, Methyl Paraben, Propyl Paraben, and Purified Water

CLINICAL PHARMACOLOGY
Entre-B combines the sympathomimetic decongestant effect of Phenylephrine with the antihistaminic action of Brompheniramine.

Phenylephrine: Phenylephrine is a decongestant which is a potent postsynaptic receptor agonist with little effect on receptors of the heart. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Phenylephrine has no effet on adrenergic receptors of the bronchi or peripheral blood vessels. Phenylephrine has a mild central stimulant effect.

Brompheniramine:
Brompheniramine is an antihistamine, H1 receptor blocking agent belonging to the alkylamine class of antihistamines. This group of antihistamines are among the most active histamine antagonists and are generally effective in relatively low doses. These drugs are not prone to produce drowsiness and are among the most suitable agents for daytime use; but again, asignificant proportion of patients do experience this effect.

INDICATIONS AND USAGE
Entre-B is indicated for the symptomatic relief of coryza, nasal congestion associated with the common cold, sinusitis, allergic rhinitis, and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease.

CONTRAINDICATIONS
Entre-B is contraindicated in patients sensitive to any of the ingredients or related compounds. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds.) Entre-B should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see PRECAUTIONS: DRUG INTERACTIONS)

WARNINGS
This product contains an antihistamine that may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Antihistamines should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck.

PRECAUTIONS
GENERAL: Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients, and therefore should be used with caution. Antihistamines may cause excitation, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, or narrow angle glaucoma.

INFORMATION FOR PATIENTS

Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery, while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase (MAO) inhibitor (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAO inhibitor drug. If patients are uncertain whether the prescription drug contains an MAO inhibitor,they should be instructed to consult a health professional before taking this product.

DRUG INTERACTIONS
MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents. Patients may develop hyperpyrexia, hypotension, nausea, myoclonic leg jerks, and coma following co-administration of MAO. Thus, concomitant administration of Entre-B and MAO inhibitors should be avoided (see CONTRAINDICATIONS).

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
No long-term animal studies have been performed with Entre-B.

PREGNANCY
Teratogenic Effects – Pregnancy Category C: Animal reproduction studies have not been conducted with Entre-B Suspension. It is also not known whether Entre-B can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Entre-B should be given to a pregnant woman only if clearly needed.

LABOR AND DELIVERY: Administration of Phenylephrine to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine bloodflow.

NURSING MOTHERS: Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Entre-B should not be administered to a nursing mother.

ADVERSE REACTIONS
The most common effects associated with antihistamines have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines and sympathomimetics, have been rare.

Other adverse reactions may include:
Dermatologic – urticaria, drug rash, photosensitivity, pruritus.
Cardiovascular – hypotension, hypertension, cardiac arrhythmias, palpitations.
Central Nervous System (CNS) – disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness,
nervousness, convulsion, headache, euphoria and dysphoria.
Genitourinary – urinary frequency, difficult urination.
Gastrointestinal – epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.
Respiratory – tightness of chest and wheezing, shortness of breath.
Hematologic – hemolytic anemia, thrombocytopenia, agranulocytosis.

OVERDOSAGE SIGNS AND SYMPTOMS
May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent.

TREATMENT: Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.

DOSAGE AND ADMINISTRATION
Entre-B: Administer the recommended dose every 12 hours.
Adults and Children over 12 years of age – 5 to 10mL (1 to 2 teaspoonfuls);
Children 6 to 12 years of age – 5 mL (1 teaspoonful);
Children under 6 years of age – consult a physician.

HOW SUPPLIED
Entre-B Suspension is available as a bubble gum flavored suspension in 4 fl. oz. bottles (NDC 42192-513-04).

STORAGE
Store at controlled room temperature, 20° - 25°C (68° - 77°F). Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure.

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

MANUFACTURED FOR
Acella Pharmaceuticals, LLC
Alpharetta, GA 30009
1-800-541-4802 Rev. 0210
Utilizing NeuvosynTM Technology

Entre-B Suspension

Antihistimine  Decongestant

Bubblegum Flavor

Each 5 mL (teaspoonful) contains:
Brompheniramine Maleate.......6 mg
Phenylephrine HCl...................10 mg

Rx Only      Shake Well

4fl oz (118 mL)

Acella Pharmaceuticals, LLC



DOSAGE AND ADMINISTRATION:
Adults and children over 12 years of age:
1 - 2 teaspoonfuls every 12 hours.
Children 6 to under 12 years of age:
1 teaspoonful every 12 hours.
Children under 6 years of age:
Consult a physician.

Dispense in a well closed, light-resistant container. Store at controlled room temperature, 20° - 25°C (68° - 77°F) [See USP]. Shake well before use.
WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
Utilizing Neuvosyn™ Technology Rev. 0210v3

Entre-B 
brompheniramine maleate, phenylephrine hcl suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42192-513
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 6 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
GLYCERIN  
XANTHAN GUM  
SACCHARIN SODIUM  
SODIUM CITRATE  
TANNIC ACID  
MAGNESIUM ALUMINUM SILICATE  
BENZOIC ACID  
METHYLPARABEN  
PROPYLPARABEN  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM (BUBBLEGUM FLAVOR) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:42192-513-04 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/11/2010
Labeler - ACELLA PHARMACEUTICALS (825380939)
Revised: 12/2010
 
ACELLA PHARMACEUTICALS



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