Valumeds Cough Relief, Dextromethorphan Hbr

Valumeds Cough Relief, Dextromethorphan Hbr
SPL v2
SPL
SPL Set ID b16a81db-d9bc-4cce-8ec2-dc189184931e
Route
ORAL
Published
Effective Date 2025-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol 400 Propylene Glycol Povidone Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 904 Shape: oval Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-20

Description

Dextromethorphan HBr, 15 mg

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Description

Dextromethorphan HBr, 15 mg

Use

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

Warnings

Directions
  • do not take more than 8 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
 age  dose
 adults and children 12 years and over  take 2 softgels every 6 to 8 hours, as need
 children under 12 years  do not use

Do Not Use

if you 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.

Other Information
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light
Package Labeling:

Inactive Ingredients

FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

Stop Use and Ask A 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Before Use If You Have
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
Active Ingredient Purpose (in Each Softgel)

Dextromethorphan HBr, 15 mg


Structured Label Content

Use

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

Purpose

Cough suppressant

Warnings

Directions
  • do not take more than 8 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
 age  dose
 adults and children 12 years and over  take 2 softgels every 6 to 8 hours, as need
 children under 12 years  do not use

Do Not Use (Do not use)

if you 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.

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light
Package Labeling:

Inactive Ingredients (Inactive ingredients)

FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

Stop Use and Ask A Doctor If (Stop use and ask a 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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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. (1-800-222-1222)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
Active Ingredient Purpose (in Each Softgel) (Active ingredient Purpose (in each softgel))

Dextromethorphan HBr, 15 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)