Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 8aee8108-a4e0-4956-8e37-6b3b1c5dc683
Route
ORAL
Published
Effective Date 2023-04-13
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 Copovidone K25-31 Povidone K90

Identifiers & Packaging

Pill Appearance
Imprint: PH073 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-27

Description

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


Medication Information

Dosage and Administration

Directions

■ Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed. Do not exceed 6 tablets in 24 hours.

■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed. Do not exceed 3 tablets in 24 hours. 

■ Children under 6 years of age: consult a doctor.   

Description

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

Uses

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold or inhaled irritants

■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

■ Helps make coughs more productive.

Section 50565-1

Keep out of reach of children. In  case of overdose, get medical help or contact a Poison Center immediately (1-800-222-1222).

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 (mucus)

Section 51727-6

Inactive Ingredients: magnesium stearate, microcrystalline cellulose, maltodextrin, povidone K30, povidone 90F, silicon dioxide, stearic acid. 

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Section 55106-9

Active ingredient - (per tablet)



Dextromethorphan Hydrobromide   20mg



Guaifenesin  400mg

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.

Other Information

Store at 15°-30°C (59°-86°F)


Structured Label Content

Uses

■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold or inhaled irritants

■ 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. Do not exceed 6 tablets in 24 hours.

■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed. Do not exceed 3 tablets in 24 hours. 

■ Children under 6 years of age: consult a doctor.   

Section 50565-1 (50565-1)

Keep out of reach of children. In  case of overdose, get medical help or contact a Poison Center immediately (1-800-222-1222).

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 (mucus)

Section 51727-6 (51727-6)

Inactive Ingredients: magnesium stearate, microcrystalline cellulose, maltodextrin, povidone K30, povidone 90F, silicon dioxide, stearic acid. 

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, 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



Guaifenesin  400mg

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.

Other Information

Store at 15°-30°C (59°-86°F)


Advanced Ingredient Data


Raw Label Data

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