Dextromethorphan Hydrobromide
FDA Label NDC 68210-1530

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals,llc for the product Dextromethorphan Hydrobromide (NDC 68210-1530). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each liquicap), purpose, uses temporarily, overdose warning, direction, other information, inactive ingredients, principal display panel - 15mg tablet shipper label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Liquicap)

Dextromethorphan Hbr 15 mg

Purpose

Cough Suppressant

Uses Temporarily

relieves cough due to minor throat and bronchial irritation may occur with a cold

Overdose Warning

In case of overdose,get medical help or contact a poison control center right away.

Direction

  • *do not take more than 8 liquidgels in any 24 hour period.
  • *adults and children 12 years over : take 2 liquidgels every 6 to 8 hours, as needed
  • *Children under 12years: ask a doctor

Other Information

  • *each tablet contains : Store at room temperature

Inactive Ingredients

FD &C Red No 40 IH, Polyethylene Glycol , Gelatin, Glycerin, Povidone, Purified water, Sorbitol

Principal Display Panel - 15Mg Tablet Shipper Label

Dextromethorphan Hydrobromide Soft Gelatin Capsules
Each Soft Gelatin Capsules Contains:
Dextromethorphan Hydrobromide USP 15mg

Lot No. :

Mfg. Date :

Exp. Date :

NDC No. : 68210-1530-4

Quantity : 4000 Capsules

Gross Wt. :

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDAAND REGULATIONS THEREUNDER

MANUFACTURED BY:
Marksans Pharma Ltd
Verna, GOA-403722,
India.
Code : GO/DRUGS/515

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS,LLC
225 LINCOLN HWY, STE # 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000; FAX.#2159434039

OMIL059

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

Principal Display Panel (15mg Tablet Shipper Label)

Principal Display Panel (15mg Tablet Shipper Label)

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