5138 V Pill — ORANGE ROUND, 8mm — Promethazine

5138 pill photo
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Imprint5138 / V
ColourORANGE
ShapeROUND
Size8
StrengthPROMETHAZINE HYDROCHLORIDE 12.5 mg
Dosage formTablet
ManufacturerQualitest Pharmaceuticals
NDC0603-5437
Schedule—
Availability—
IngredientsPROMETHAZINE HYDROCHLORIDE[PROMETHAZINE]

What does this imprint mean?

The imprint "5138 V" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Promethazine

Uses and warnings

BOXED WARNING: "Promethazine hydrochloride should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression," and caution is advised in older pediatric patients because fatal respiratory depression has occurred even at recommended doses. Other key warnings/contraindications: comatose states and hypersensitivity to phenothiazines; respiratory depression risk in patients with compromised respiratory function (e.g., COPD, sleep apnea); CNS/psychomotor impairment affecting driving; lowered seizure threshold; and risk of neuroleptic malignant syndrome.

Promethazine Hydrochloride Tablets are indicated for allergic conditions such as perennial and seasonal allergic rhinitis, allergic conjunctivitis, urticaria, and angioedema; amelioration of allergic reactions to blood or plasma; dermographism; anaphylaxis as adjunctive therapy; active and prophylactic treatment of motion sickness; prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery; sedation and relief of apprehension with production of light sleep; and as an adjunct to analgesics for postoperative pain control.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file a0c79862-2b12-4dcc-a69b-72800d08b597.xml