Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 6046dc50-f162-4e2d-aa3c-7d27efad477d
Route
ORAL
Published
Effective Date 2021-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Cellulose, Microcrystalline Maltodextrin Stearic Acid Povidone K30 Povidone K90

Identifiers & Packaging

Pill Appearance
Imprint: PH073 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-15

Description

Dextromethorphan Hydrobromide   20mg Guaifenesin  400mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan Hydrobromide   20mg Guaifenesin  400mg

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.

Section 51945-4

Warnings

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.

Directions

Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.

Children 6 to 10 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)

Inactive Ingredients

Magnesium Stearate, Microcrystalline Cellulose. Silicon Dioxide, Maltodextrin, Stearic acid, Povidone K30, Povidone 90F

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.

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 Center immediately.

Active Ingredients (per Tablet)

Dextromethorphan Hydrobromide   20mg

Guaifenesin  400mg

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 (mucus)


Structured Label Content

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.

Section 51945-4 (51945-4)

Purpose

Cough Suppressant

Expectorant

Warnings

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.

Directions

Adults and children 12 years of age and over:take 1 tablet every 4 hours as needed.

Children 6 to 10 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)

Inactive Ingredients (Inactive ingredients)

Magnesium Stearate, Microcrystalline Cellulose. Silicon Dioxide, Maltodextrin, Stearic acid, Povidone K30, Povidone 90F

Stop Use and Ask Doctor If (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.

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 Center immediately.

Active Ingredients (per Tablet) (Active ingredients - (per tablet))

Dextromethorphan Hydrobromide   20mg

Guaifenesin  400mg

Ask Doctor Before Use If You Have (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 (mucus)


Advanced Ingredient Data


Raw Label Data

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