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ADVERSE REACTIONS: The most common adverse reactions to BP 8 Cough Suspension include nausea, cardiac palpitations, increased irritability or excitement, headache, dizziness, tachycardia, diarrhea, drowsiness, stomach pain, seizures, slowed heart rate, shortness of breath and/or troubled breathing.

CLINICAL PHARMACOLOGY: Dextromethorphan is an antitussive agent, which unlike the isomeric levorphanol has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage, Dextromethorphan does not inhibit ciliary activity. Dextromethorphan is rapidly absorbed from the gastrointestinal tract, metabolized by the liver and excreted primarily in the urine. Pseudoephedrine is a sympathomimetic which acts predominantly on alpha adrenergic receptors in the mucosa of the respiratory tract producing vasoconstriction and has little action on beta receptors. It therefore functions as an oral nasal decongestant with minimal CNS stimulation. Guaifenesin is an expectorant, which increases the output of phlegm (sputum) and bronchial secretions by reducing adhesiveness and surface tension. The increased flow of less viscid secretions promotes ciliary actions and changes a dry, unproductive cough to one that is more productive and less frequent.

CONTRAINDICATIONS: BP 8 Cough Suspension is contraindicated in patients with a known hypersensitivity to any of its ingredients. It is also contraindicated in patients with severe hypertension, severe coronary artery disease and patients on MAO inhibitor therapy. BP 8 Cough Suspension should not be used during pregnancy or in nursing mothers. Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. The elderly (60 years or older) are more likely to exhibit adverse reactions. At dosages higher than the recommended dose, nervousness, dizziness or sleeplessness may occur.

DESCRIPTION: BP 8 Cough Suspension is an alcohol-free, grape-flavored antitussive/decongestant/expectorant suspension for oral administration. Each teaspoonful (5 mL) contains: Dextromethorphan Hydrobromide ..................... 15 mg Pseudoephedrine Hydrochloride ........................ 30 mg Guaifenesin ...................................................... 175 mg Inactive Ingredients: methylparaben, propylparaben, benzoic acid, citric acid, sodium saccharin, grape flavor, natural masking flavor, purple dye, xanthan gum, glycerin, propylene glycol and sorbitol.

DOSAGE AND ADMINISTRATION: Adults and children over 12 years of age: 2 teaspoonfuls 3 times a day. Children 6 to under 12 years of age: 1 teaspoonful 3 times a day. Children 6 years of age and under: As directed by a physician

HOW SUPPLIED: BP 8 Cough Suspension, each teaspoonful (5 mL) is supplied as a grape-flavored suspension in 16 ounce (473 mL) bottles, NDC 42192-507-16. STORAGE REQUIREMENTS: Store at controlled room temperature 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.] KEEP BOTTLE TIGHTLY CLOSED. 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 . Rx Only All prescription substitutions 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, incipients, inactive ingredients and chemical formulation information provided herein. MANUFACTURED FOR: Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009

INDICATIONS AND USAGE: BP 8 Cough Suspension is indicated for temporary relief of nasal congestion and dry non-productive cough associated with the common cold and other respiratory allergies. Helps drainage of the bronchial tubes by thinning mucus.

OVERDOSAGE: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF SUSPECTED OVERDOSE, IMMEDIATELY CALL A POISON CONTROL CENTER AND/OR SEEK PROFESSIONAL ASSISTANCE. Symptoms: Overdosage with Pseudoephedrine includes anxiety, tenseness, respiratory difficulty, headache and awareness of a slow forceful heartbeat.

PRODUCT PACKAGING: The packaging below represents the labeling currently used: Principal display panel and side panel for 473 mL label: NDC 42192-507-16 BP 8 Cough Grape Flavored Each teaspoonful (5 mL) contains: Dextromethorphan Hydrobromide ..................... 15 mg Pseudoephedrine Hydrochloride ........................ 30 mg Guaifenesin ...................................................... 175 mg Rx ONLY 1 Pint (16 fl oz / 473 mL) Acella PHARMACEUTICALS, LLC Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature]. Excursions permitted to 15°- 30°C (59°- 86°F). Avoid freezing. Protect from light. Dispense in a tight, light-resistant cap. Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 BP8C.jpg

PRECAUTIONS: General : Caution should be exercised in patients with high blood pressure, heart disease, diabetes or thyroid disease and in patients who exhibit difficulty in urination due to enlargement of the prostate gland. Check with a physician if symptoms do not improve within 7 days or if accompanied by high fever, rash or persistent headache. Drug Interactions : Do not take BP 8 Cough Suspension if you are presently taking a prescription drug for high blood pressure or depression, without first consulting with a physician. MAO Inhibitor therapy and beta adrenergic blockers may increase the effect of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Pseudoephedrine Hydrochloride may increase the possibility of cardiac arrhythmias in patients presently taking digitalis glycosides. Dextromethorphan should be used with caution in sedated or debilitated patients and in patients confined to supine positions. Carcinogenesis, Mutagenesis, Impairment of Fertility : No data is currently available on long-term potential for carcinogenesis, mutagenesis or impairment of fertility in animals or humans. Use in Pregnancy : Pregnancy Category C: Animal reproduction studies have not been conducted with BP 8 Cough Suspension. It is also not known whether BP 8 Cough Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BP 8 Cough Suspension should be given to a pregnant woman only if clearly needed. Nursing Mothers : Pseudoephedrine is excreted in human milk; use by nursing mothers is not recommended because of the higher than usual risk of side effects from sympathomimetic amines for infants, especially newborn and premature infants. It is not known whether Guaifenesin or Dextromethorphan is excreted in human milk, caution should be exercised when Guaifenesin or Dextromethorphan is administered to a nursing mother and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Geriatrics : Pseudoephedrine should be used with caution in the elderly because they may be more sensitive to the effects of the sympathomimetics.

BP 8 Cough Suspension Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE GUAIFENESIN GUAIFENESIN METHYLPARABEN PROPYLPARABEN BENZOIC ACID CITRIC ACID ACETATE Saccharin Sodium GRAPE PURPLE DYE MUREX XANTHAN GUM GLYCERIN PROPYLENE GLYCOL SORBITOL Grape Flavor

WARNINGS: Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema or where excessive secretions accompany cough, except under the advice and supervision of the physicians. BP 8 Cough Suspension should be taken a few hours prior to bedtime to minimize the possibility of sleeplessness.