drug facts

drug facts
SPL v7
SPL
SPL Set ID a40f5893-eb96-4e0e-b965-d78293c48dc9
Route
oral
Published
Effective Date 2014-04-04
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

Identifiers & Packaging

Pill Appearance
Imprint: PH073 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
otc monograph drug active Since 2012-08-01

Description

Active ingredient - (per tablet) 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.

Active Ingredient

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

■ 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 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)

Description

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

Section 50565-1

Keep out of reach of children. In  case 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 (mucus)

Section 51727-6

Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, 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


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.

Active Ingredient (55106-9)

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

■ 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 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)

Section 50565-1 (50565-1)

Keep out of reach of children. In  case 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 (mucus)

Section 51727-6 (51727-6)

Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, 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


Advanced Ingredient Data


Raw Label Data

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