NEOTUSS S/F GRAPE-MENTHOL FLAVOR- guaifenesin, dextromethorphan hbr liquid 
DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals

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NeoTuss S/F Grape-Menthol Flavor

Guaifenesin 200 mg / 5 mL – Purpose: Expectorant

Dextromethorphan HBr 30 mg / 5 mL – Purpose: Antitussive

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

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.

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.

Expectorant and Antitussive (cough suppressant)

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.

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

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.

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.

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).

Package Label - Principal Display Panel

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

NeoTUSS S/F label

NEOTUSS S/F  GRAPE-MENTHOL FLAVOR
guaifenesin, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12539-555
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12539-555-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product02/28/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/28/2025
Labeler - DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals (076007996)
Establishment
NameAddressID/FEIBusiness Operations
DEXTRUM LABORATORIES INC007392322manufacture(12539-555)

Revised: 2/2025
Document Id: 2f3df82c-1927-5238-e063-6294a90a7bbf
Set id: 2f3df82c-1926-5238-e063-6294a90a7bbf
Version: 1
Effective Time: 20250228
 
DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals