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

Purpose

Cough suppressant

Description

Dextromethorphan HBr 15 mg


Medication Information

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.

Uses

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

Purpose

Cough suppressant

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

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

Description

Dextromethorphan HBr 15 mg

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.

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

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.

Uses

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

Purpose

Cough suppressant

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

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

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.

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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