Akin Cough Formula Dm (strawberry - Banana)

Akin Cough Formula Dm (strawberry - Banana)
SPL v2
SPL
SPL Set ID 7a81efd8-775d-455e-860f-f3e3b369a0a7
Route
TOPICAL
Published
Effective Date 2023-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Glycerin Methylparaben Potassium Sorbate Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-01

Description

Dextromethorphan HBr USP 10 mg Guaifenesin USP 100 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Dextromethorphan HBr USP 10 mg Guaifenesin USP 100 mg

Uses

• temporarily quiets cough associated with the common cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Directions

Do not take more than 6 doses in any 24 hours period

Adults and children 12 years and over 10 ml (2 teaspoonfuls every 4 hours or as directed by doctor)
Children under 12 years do not use
Do Not Use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.

Drug Facts

Other Information

• store at room temperature • 15°-30°C (59°-86°F)

Do not use if seal under cap is torn, broken or missing. TAMPER-EVIDENT:

Package Labeling:

Inactive Ingredients

Citric acid, FD&C red #40, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.

Ask A Doctor Before Use If

• you have a cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough occurs with too much phlegm (mucus)

Stop Use and Ask A Doctor If

• cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Beast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 5ml Tsp.)

Dextromethorphan HBr USP 10 mg

Guaifenesin USP 100 mg


Structured Label Content

Uses

• temporarily quiets cough associated with the common cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Purpose

Cough suppressant

Expectorant

Directions

Do not take more than 6 doses in any 24 hours period

Adults and children 12 years and over 10 ml (2 teaspoonfuls every 4 hours or as directed by doctor)
Children under 12 years do not use
Do Not Use (Do not use)

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.

Drug Facts

Other Information (Other information)

• store at room temperature • 15°-30°C (59°-86°F)

Do not use if seal under cap is torn, broken or missing. TAMPER-EVIDENT:

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Citric acid, FD&C red #40, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, strawberry-banana flavor, sucralose.

Ask A Doctor Before Use If (Ask a doctor before use if)

• you have a cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough occurs with too much phlegm (mucus)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Beast Feeding, (If pregnant or beast-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 Control Center right away.

Active Ingredient (in Each 5ml Tsp.) (Active ingredient (in each 5ml tsp.))

Dextromethorphan HBr USP 10 mg

Guaifenesin USP 100 mg


Advanced Ingredient Data


Raw Label Data

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