Cough Relief

Cough Relief
SPL v5
SPL
SPL Set ID 12a14331-58e5-42dd-81c6-c53f62804d7b
Route
ORAL
Published
Effective Date 2021-11-17
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 Sorbitol Solution Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 904 Shape: capsule Color: red Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-17

Description

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Description

Dextromethorphan HBr 15 mg

Uses

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

Warnings

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.

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
 adults & children 12 years & over  take 2 softgels every 6 to 8 hours, as needed
 children under 12 years of age  do not use

Drug Facts

Display Panel

PACKAGE NOT CHILD-RESISTANT

CABINET

Cough Relief

Active ingredient: DEXTROMETHORPHAN HBr 15 MG

Cough Suppressant

Relieves Cough up to 8 Hours

Non-Drowsy

Non-Narcotic

CABINET: The Sustainable Healthcare Co.™

Distributed By: 

Cabinet Health P.B.C.

Other Information

• store at 20–25°C (68–77°F) • avoid excessive heat above 40°C (104°F) • protect from light

Inactive Ingredients

FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone,sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

1-888-333-9792

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)

Active Ingredient (in Each Tablet)

Dextromethorphan HBr 15 mg

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


Structured Label Content

Uses

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

Purpose

Cough suppressant

Warnings

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.

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
 adults & children 12 years & over  take 2 softgels every 6 to 8 hours, as needed
 children under 12 years of age  do not use

Drug Facts

Display Panel

PACKAGE NOT CHILD-RESISTANT

CABINET

Cough Relief

Active ingredient: DEXTROMETHORPHAN HBr 15 MG

Cough Suppressant

Relieves Cough up to 8 Hours

Non-Drowsy

Non-Narcotic

CABINET: The Sustainable Healthcare Co.™

Distributed By:  (Distributed by: )

Cabinet Health P.B.C.

Other Information (Other information)

• store at 20–25°C (68–77°F) • avoid excessive heat above 40°C (104°F) • protect from light

Inactive Ingredients (Inactive ingredients)

FD&C Red No. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone,sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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)

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Dextromethorphan HBr 15 mg

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


Advanced Ingredient Data


Raw Label Data

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