Brompheniramine / dextromethorphan / pseudoephedrine

Relief of cough and upper-respiratory symptoms, including nasal congestion, associated with allergy or common cold. Selected Alkem product is prescription oral syrup under ANDA 210647; FDA records original approval July 14, 2020. This status is product specific and does not establish approval for every similarly named syrup.

This profile covers the precise 2 mg / 10 mg / 30 mg per 5 mL combination. Different concentrations, two-ingredient products, extended-release forms and OTC products have separate instructions. Antihistamines should not be used to treat lower-respiratory conditions, including asthma. Do not infer disease modification, antibiotic action or an infant benefit from a symptom-relief indication.

The label retains physician-established dosing for six months to under two and says below-six-month safety/effectiveness are unestablished. FDA advises against cough/cold products containing a decongestant or antihistamine below two because potentially fatal harm can occur. No infant dose is supplied here. Obtain pediatric review before treating a young child; the table records selected prescription labeling, not permission for caregiver self-selection. FDA also reports voluntary OTC under-four relabeling; do not silently apply that as a new formal contraindication in this prescription label.

Use a calibrated oral syringe/cup in mL, verify all three ingredients and avoid household teaspoon estimates. Do not exceed six doses, shorten intervals or combine another product with the same ingredients. Selected labeling gives no numeric renal/hepatic adjustment or universal duration/stopping algorithm; use the clinician’s plan, with reassessment for persistent/worsening symptoms. A missed dose does not justify doubling.

Selected label excludes ingredient hypersensitivity, newborns, premature infants, nursing mothers, severe hypertension and severe coronary artery disease. Do not use dextromethorphan with MAO inhibitors. Antihistamines should not treat lower-respiratory conditions including asthma; history of bronchial asthma is separately listed as a precaution.

The selected current label has no boxed warning. Its serious pediatric overdose, MAOI and cardiovascular contraindications still apply; absence of a box is not evidence of a safe infant regimen.

Most frequent effects are sedation, dryness of mouth/nose/throat, thickened bronchial secretions and dizziness. Other reported effects include insomnia or excitation, tremor, blurred vision, GI upset/constipation, urinary difficulty, BP changes, palpitations/arrhythmias, rash and wheezing. Serious blood disorders and seizures are also reported; the label supplies no dependable frequency for these less-common reports.

Concurrent MAOI use is contraindicated: dextromethorphan combinations have produced hyperthermia, hypotension and death; MAO inhibition may also intensify antihistamine anticholinergic effects and pseudoephedrine effects. Selected label does not supply a precise washout interval. A prescriber/pharmacist must resolve current or recent MAOI treatment and any serotonergic medication combination rather than inferring safety from this label’s short list.

Alcohol, hypnotics, sedatives, tranquilizers and other CNS depressants add to antihistamine effects. Pseudoephedrine may reduce antihypertensive effect. Review every prescription/OTC product for these agents and the three active ingredients to prevent duplication; do not add sleep aids or adult cold products to a child’s regimen.

Combination reproduction studies and adequate human fetal-risk evidence are lacking; the label’s historical pregnancy-category wording does not establish safety. It directs use during pregnancy only if clearly needed. Nursing mothers are contraindicated because of infant antihistamine intolerance risk, particularly in newborns/prematures; do not replace this selected product restriction with an assumed class-wide compatible-with-breastfeeding claim.

Below six months safety/effectiveness are unestablished and newborns/prematures are contraindicated. FDA under-two advice takes priority over uncritical reuse of the label’s physician-established infant language. Older adults are more susceptible to dizziness, sedation, hypotension and sympathomimetic adverse effects; cautious low-end selection is advised and trial numbers at sixty-five or older were insufficient to establish equivalent response.

The selected label gives no creatinine-clearance, dialysis or hepatic-severity dosing table. Decreased renal/hepatic/cardiac function contributes to cautious older-adult dosing. Absence of a numeric adjustment does not establish unchanged exposure or safety in severe impairment; arrange individual review rather than invent a percentage reduction.

Brompheniramine antagonizes histamine H1 activity and also has anticholinergic/sedating effects. Pseudoephedrine promotes alpha-adrenergic nasal vasoconstriction. Dextromethorphan acts centrally to increase the cough threshold; this does not make it an asthma medicine.

The label reports brompheniramine peak around five hours after a single 4 mg oral dose, mainly urinary elimination of metabolites and presumed hepatic metabolism. Pseudoephedrine effects begin within about thirty minutes, peak activity about one hour; antitussive onset is about fifteen to thirty minutes. It supplies no validated combination half-life or organ-impairment PK algorithm. No abuse-safety or absence-of-dependence claim is inferred from historical nonaddictive wording.

Verify concentration, age, written dose and calibrated measuring device. Review sedation/excitation, BP/palpitations, urinary problems and breathing symptoms; persistent or worsening illness needs clinical reassessment. Avoid alcohol/hazardous driving and duplicate cough/cold medicines. Review pregnancy, nursing and current/recent MAO inhibitors before dispensing. FDA describes cool-mist humidification, saline and fluids as supportive options for children; use age-appropriate care.

Seek emergency or Poison Control advice for suspected extra doses or a child’s ingestion. Toxicity can involve CNS depression or agitation, anticholinergic effects, hypertension, arrhythmias and seizures. The selected older treatment text includes induced emesis and other interventions; these are not supplied as home instructions or a validated modern universal protocol. Do not interpret historical survived ingestions as safe doses.

Manufacturer / distributor

Alkem Laboratories / Ascend Laboratories

Appearance

Clear light pink, butterscotch-flavored oral syrup

Small bottle

118 mL · NDC 67877-558-17

Large bottle

473 mL · NDC 67877-558-16

Each 5 mL contains brompheniramine maleate 2 mg, dextromethorphan hydrobromide 10 mg and pseudoephedrine hydrochloride 30 mg. Selected vehicle includes alcohol 0.95% v/v, sucrose and FD&C Red 40. Verify excipients for the actual product; do not substitute phenylephrine, dexbrompheniramine or a different concentration from the name alone.

Store selected product at 20–25°C, keep tightly closed and dispense in a tight light-resistant container. Secure from children; follow the actual expiration. No manufacturer-independent refrigeration rule, freezing permission or compounded beyond-use date is supplied.