Akin Cough Formula Dm Strawberry Banana Liquid
FDA Label NDC 69822-211

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Service, Inc. for the product Akin Cough Formula Dm Strawberry Banana (NDC 69822-211). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient (in each 5ml tsp.), purpose, uses, do not use, ask a doctor before use if, stop use and ask a doctor if, if pregnant or beast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient (In Each 5Ml Tsp.)

Dextromethorphan HBr USP 10 mg

Guaifenesin USP 100 mg

Purpose

Cough suppressant

Expectorant

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.

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.

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.

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

Other Information

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

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

Inactive Ingredients

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

Package Labeling:

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