Drug Facts Topcare Tab Tussin Dm

Drug Facts Topcare Tab Tussin Dm
SPL v2
SPL
SPL Set ID 89df0de0-cc40-4e0e-bad0-5eb66e187471
Route
ORAL
Published
Effective Date 2021-05-06
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 Povidone K30 Maltodextrin Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PH073 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-05-06

Description

Dextromethorphan Hydrobromide   20mg   Cough Suppressant Guaifenesin  400mg  Expectorant

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan Hydrobromide   20mg   Cough Suppressant Guaifenesin  400mg  Expectorant

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
Warning

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 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

Do Not Use

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.

Display Panel

Inactive Ingredients

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

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)

Pregnant Or Breastfeeding

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

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

Keep Out of Reach of Children,

In case of overdose, get medical help or contact a Poison Center immediately

Active Ingredient (per Tablet)

Dextromethorphan Hydrobromide   20mg   Cough Suppressant

Guaifenesin  400mg  Expectorant


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
Purpose

Cough Suppressant

Expectorant

Warning

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 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

Do Not Use (Do not use)

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.

Display Panel (Display panel)

Inactive Ingredients (Inactive ingredients)

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

Ask Doctor Before Use (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)

Pregnant Or Breastfeeding (Pregnant or breastfeeding)

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

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

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 Ingredient (per Tablet) (Active ingredient - (per tablet))

Dextromethorphan Hydrobromide   20mg   Cough Suppressant

Guaifenesin  400mg  Expectorant


Advanced Ingredient Data


Raw Label Data

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