Drug Facts Cvs Congestion Relief Dm

Drug Facts Cvs Congestion Relief Dm
SPL v4
SPL
SPL Set ID 5a2d0464-038d-4c3f-b39e-ee9984fb383e
Route
ORAL
Published
Effective Date 2018-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Magnesium Stearate Cellulose, Microcrystalline Silicon Dioxide Copovidone Maltodextrin Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH073 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-12-07

Description

Active ingredient - (per tablet) Dextromethorphan Hydrobromide   20mg   Cough Suppressant Guaifenesin  400mg  Expectorant


Medication Information

Warnings and Precautions

Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains

an MAIO, ask your doctor or pharmacist before using this product.

Indications and Usage

Uses. temporarily relieves cough due to minor throat and bronchial irritation

as may occur with a common cold • helps loosen phlegm (mucus) and thin

bronchial secretions to rid the bronchial passageways of bothersome mucus

• helps make coughs more productive

Dosage and Administration

Directions        

• Adults and children 12 years of age and over:    

take 1 tablet every 4 hours as needed    

• Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed

• Children under 6 years of age: consult a doctor    

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other information store at 15'- 30' C (59'- 86'F)     Rev 10/U9 RCCF

Description

Active ingredient - (per tablet) Dextromethorphan Hydrobromide   20mg   Cough Suppressant Guaifenesin  400mg  Expectorant

Section 50565-1

Keep out of reach of children, In  ase of overdose, get medical help or contact a Poison Center immediately

Section 50566-9

Stop use and ask doctor if

Symptoms are accompanied by fever, rash or persistent headache

cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition



Section 50569-3

Ask doctor before use if you have

persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma

cough is accompanied by excessive phlegm (mucous)

Section 50570-1

Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains

an MAIO, ask your doctor or pharmacist before using this product.

Section 51727-6

magnesium stearate, microcrystalline cellulose,

 colloidal silicon dioxide, (co) povidone, dicalcium

phosphate, maltodextrin, sodium starch glycolate, stearic acid

Section 51945-4

Enter section text here

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Section 55106-9

Active ingredient - (per tablet)

Dextromethorphan Hydrobromide   20mg   Cough Suppressant

Guaifenesin  400mg  Expectorant


Structured Label Content

Indications and Usage (34067-9)

Uses. temporarily relieves cough due to minor throat and bronchial irritation

as may occur with a common cold • helps loosen phlegm (mucus) and thin

bronchial secretions to rid the bronchial passageways of bothersome mucus

• helps make coughs more productive

Dosage and Administration (34068-7)

Directions        

• Adults and children 12 years of age and over:    

take 1 tablet every 4 hours as needed    

• Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed

• Children under 6 years of age: consult a doctor    

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other information store at 15'- 30' C (59'- 86'F)     Rev 10/U9 RCCF

Warnings and Precautions (34071-1)

Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains

an MAIO, ask your doctor or pharmacist before using this product.

Section 50565-1 (50565-1)

Keep out of reach of children, In  ase of overdose, get medical help or contact a Poison Center immediately

Section 50566-9 (50566-9)

Stop use and ask doctor if

Symptoms are accompanied by fever, rash or persistent headache

cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition



Section 50569-3 (50569-3)

Ask doctor before use if you have

persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma

cough is accompanied by excessive phlegm (mucous)

Section 50570-1 (50570-1)

Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains

an MAIO, ask your doctor or pharmacist before using this product.

Section 51727-6 (51727-6)

magnesium stearate, microcrystalline cellulose,

 colloidal silicon dioxide, (co) povidone, dicalcium

phosphate, maltodextrin, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

Enter section text here

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active ingredient - (per tablet)

Dextromethorphan Hydrobromide   20mg   Cough Suppressant

Guaifenesin  400mg  Expectorant


Advanced Ingredient Data


Raw Label Data

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