1e92cbc2-8ec7-442e-a6ec-d069080c53fd

SPL v1
SPL
SPL Set ID 1e92cbc2-8ec7-442e-a6ec-d069080c53fd
Route
oral
Published
Effective Date 2013-05-21
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (15 mg)
Inactive Ingredients
gelatin sorbitan sorbitol fd&c blue no. 1 water polyethylene glycol 400 povidone k30 glycerin fd&c red no. 40 propylene glycol

Identifiers & Packaging

Pill Appearance
Imprint: 26 Shape: capsule Color: red Size: 13 mm Score: 1
Marketing Status
otc monograph final active Since 2013-05-22
Purpose

Cough Suppressant 

Description

Dextromethorphan HBr, USP 15 mg 

Medication Information

Warnings


DO NOT USEYou are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

 

Purpose

Cough Suppressant 

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

Gelatin, Sorbitol, Sorbitan, FD&C Blue No.1, Water, Polyethylene Glycol 400, Povidone K-30, Glycerine, FD&C Red No. 40, Propylene Glycol.

Description

Dextromethorphan HBr, USP 15 mg 

Principal Display Panel

CARTON LABEL PDP



NDC # 68016-026-20



Adult Long-Lasting Cough Relief

DEXTROMETHORPHAN HBr, USP 15mg

COUGH SUPPRESSANT



Relieves cough for upto 8 hours

Non-drowsy

Non-Narcotic formula



20 softgels











BOTTLE LABEL PDP



NDC # 68016-026-20



Adult Long-Lasting Cough Relief

DEXTROMETHORPHAN HBr, USP 15mg

COUGH SUPPRESSANT



Relieves cough for about 8 hours

Non-Drowsy

Non-Narcotic Formula



20 Softgels







Use(s)

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

Storage
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 
  • store at 20º-25ºC (68º-77ºF)
  • avoid excessive heat above 40ºC (104ºF)
  • protect from light
  • use by expiration date on package
Active Ingredient(s)

Dextromethorphan HBr, USP 15 mg 

Pregnancy/breastfeeding

Ask a health professional before use.

Ask A Doctor Before Use If
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema 
Stop Use and Ask Doctor If

Cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings (WARNINGS)


DO NOT USEYou are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

 

Purpose (PURPOSE)

Cough Suppressant 

Directions (DIRECTIONS)
  • do not take more than 8 liquidgels in any 24-hour period
  • adults and children 12 years and over: take 2 liquidgels every 6 to 8 hours, as needed 
  • children under 12 years: ask a doctor
Inactive Ingredients (INACTIVE INGREDIENTS)

Gelatin, Sorbitol, Sorbitan, FD&C Blue No.1, Water, Polyethylene Glycol 400, Povidone K-30, Glycerine, FD&C Red No. 40, Propylene Glycol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CARTON LABEL PDP



NDC # 68016-026-20



Adult Long-Lasting Cough Relief

DEXTROMETHORPHAN HBr, USP 15mg

COUGH SUPPRESSANT



Relieves cough for upto 8 hours

Non-drowsy

Non-Narcotic formula



20 softgels











BOTTLE LABEL PDP



NDC # 68016-026-20



Adult Long-Lasting Cough Relief

DEXTROMETHORPHAN HBr, USP 15mg

COUGH SUPPRESSANT



Relieves cough for about 8 hours

Non-Drowsy

Non-Narcotic Formula



20 Softgels







Use(s) (USE(S))

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

Storage (STORAGE)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 
  • store at 20º-25ºC (68º-77ºF)
  • avoid excessive heat above 40ºC (104ºF)
  • protect from light
  • use by expiration date on package
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Dextromethorphan HBr, USP 15 mg 

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

Ask a health professional before use.

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema 
Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

Cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:37.855824 · Updated: 2026-03-14T22:53:29.712463