NEOTUSS S/F GRAPE-MENTHOL FLAVOR- guaifenesin, dextromethorphan hbr liquid

NeoTuss S/F by

Drug Labeling and Warnings

NeoTuss S/F by is a Otc medication manufactured, distributed, or labeled by DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals, DEXTRUM LABORATORIES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Guaifenesin 200 mg / 5 mL – Purpose: Expectorant

Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive

INACTIVE INGREDIENT

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

INDICATIONS & 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 & 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.

PURPOSE

Expectorant and Antitussive (cough suppressant)

WHEN USING

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.

KEEP OUT OF REACH OF CHILDREN

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

WARNINGS

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.

STOP 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 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.

OTHER SAFETY INFORMATION

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).

PRINCIPAL DISPLAY PANEL

Package Label - Principal Display Panel

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

INGREDIENTS AND APPEARANCE

NEOTUSS S/F  GRAPE-MENTHOL FLAVOR
guaifenesin, dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12539-555
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)	7.55 mg  in 5 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.85 mg  in 5 mL
SUCRALOSE (UNII: 96K6UQ3ZD4)	3.35 mg  in 5 mL
SORBITOL (UNII: 506T60A25R)	1250 mg  in 5 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	750 mg  in 5 mL
GLYCERIN (UNII: PDC6A3C0OX)	1750 mg  in 5 mL
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)	2.1 mg  in 5 mL
MENTHOL (UNII: L7T10EIP3A)	0.4 mg  in 5 mL
WATER (UNII: 059QF0KO0R)	1023 mg  in 5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12539-555-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/28/2025

Labeler - DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals (076007996)

Establishment
Name	Address	ID/FEI	Business Operations
DEXTRUM LABORATORIES INC		007392322	manufacture(12539-555)