Neotuss S/f Grape-menthol Flavor

Neotuss S/f Grape-menthol Flavor
SPL v2
SPL
SPL Set ID 2f3df82c-1926-5238-e063-6294a90a7bbf
Route
ORAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (7.55 mg) Dextromethorphan (0.85 mg)
Inactive Ingredients
Methylparaben Propylparaben Sucralose Propylene Glycol Glycerin Hydroxyethylcellulose Menthol Water Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-28

Description

Guaifenesin 200 mg / 5 mL – Purpose: Expectorant Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive


Medication Information

Warnings and Precautions

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician.

Do not take this product for persistent cough or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician.

Indications and Usage

Temporarily relieves cough due to minor bronchial irritations as may occur with the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Adults and children over 12 years of age: Oral dose in one teaspoonful (5 mL) every 6-8 hours, or as directed by a physician.

Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.

Children under 6 years of age: Only as directed by a physician.

Dosage and Administration

Adults and children over 12 years of age: Oral dose in one teaspoonful (5 mL) every 6-8 hours, or as directed by a physician.

Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.

Children under 6 years of age: Only as directed by a physician.

Description

Guaifenesin 200 mg / 5 mL – Purpose: Expectorant Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive

Section 50565-1

In case of accidental overdose, seek the advice of a health professional or contact a Poison Control Center immediately.

Section 50566-9

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 are uncertain whether your prescription drug contains a MAOI, consult a health professional before taking this product.

If pregnant or breast-feeding, ask a health professional before using this product.

Section 50567-7

Temporarily relieves cough due to minor bronchial irritations as may occur with the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Section 51727-6

Artificial and natural flavors, glycerin, hydroxyethylcellulose, menthol, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, and sucralose.

Section 51945-4

Package Label - Principal Display Panel

1 FL. OZ (30 mL) NDC: 12539-555-01

Section 55105-1

Expectorant and Antitussive (cough suppressant)

Section 55106-9

Guaifenesin 200 mg / 5 mL – Purpose: Expectorant

Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive

Section 60561-8

Shake well before use.

Do not use this product if the seal is torn, broken or missing.

Pharmacist: Preserve and dispense in tight, light-resistant containers as defined in the USP.

Store between 15°-30°C (59°-86°F).


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves cough due to minor bronchial irritations as may occur with the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Adults and children over 12 years of age: Oral dose in one teaspoonful (5 mL) every 6-8 hours, or as directed by a physician.

Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.

Children under 6 years of age: Only as directed by a physician.

Dosage and Administration (34068-7)

Adults and children over 12 years of age: Oral dose in one teaspoonful (5 mL) every 6-8 hours, or as directed by a physician.

Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 6-8 hours, or as directed by a physician.

Children under 6 years of age: Only as directed by a physician.

Warnings and Precautions (34071-1)

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician.

Do not take this product for persistent cough or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician.

Section 50565-1 (50565-1)

In case of accidental overdose, seek the advice of a health professional or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

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 are uncertain whether your prescription drug contains a MAOI, consult a health professional before taking this product.

If pregnant or breast-feeding, ask a health professional before using this product.

Section 50567-7 (50567-7)

Temporarily relieves cough due to minor bronchial irritations as may occur with the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Section 51727-6 (51727-6)

Artificial and natural flavors, glycerin, hydroxyethylcellulose, menthol, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, and sucralose.

Section 51945-4 (51945-4)

Package Label - Principal Display Panel

1 FL. OZ (30 mL) NDC: 12539-555-01

Section 55105-1 (55105-1)

Expectorant and Antitussive (cough suppressant)

Section 55106-9 (55106-9)

Guaifenesin 200 mg / 5 mL – Purpose: Expectorant

Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive

Section 60561-8 (60561-8)

Shake well before use.

Do not use this product if the seal is torn, broken or missing.

Pharmacist: Preserve and dispense in tight, light-resistant containers as defined in the USP.

Store between 15°-30°C (59°-86°F).


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