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

Purpose

Cough Suppressant Expectorant

Description

Dextromethorphan Hydrobromide   20mg Guaifenesin  400mg


Medication Information

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.

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.

Purpose

Cough Suppressant

Expectorant

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

Description

Dextromethorphan Hydrobromide   20mg Guaifenesin  400mg

Section 51945-4

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

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.

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.

Purpose

Cough Suppressant

Expectorant

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

Section 51945-4 (51945-4)

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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